For The Defense, November 2012 - DRI Today

On The Record 

Embracing the Process of Transformation 

DRI and the 21st Century Lawyer 

By Mary Massaron Ross, DRI President 

Lawyer and former president of Dartmouth College 

James O. Freedman said, “Both strands of learning, 

the literary and the legal, concern themselves with the 

dilemma of the human condition.” According to Freedman, 

the “consequences of individual decisions and 

actions, the tolerance of conflicting views, the balancing 

of justice and mercy, freedom and authority… are 

the grist of the novelist’s imagination, the poet’s vision, 

the essayist’s insight, no less than a lawyer’s craft.” I 

have always believed, along with Justice Felix Frankfurter, 

that the “best way to come to the study of law is to 

come to the study of law as a well-read person.” The law, 

like great literature, happens at the intersection of the 

abstract and the particular, the logical and the intuitive, 

the uniform and the unique. According to William Styron, 

“A good book should leave you… slightly exhausted 

at the end. You live several lives while reading it.” And 

it is just this process that makes the world of books so 

helpful to those of us trying to deepen our understanding 

of people and of this global world. 

Since childhood, I have spent many of my happiest 

hours curled up in a chair reading. If you visit my 

home in the Detroit area, you will see books spilling 

out of bookcases, stacked on end tables, and occasionally 

piled on the floor. If you stop by my office, the 

books are two-deep on the shelves that line several of the 

walls. And when the guards check my purse as I enter a 

courthouse or go through the airport security line, they 

inevitably see a Kindle (with several hundred books 

downloaded on it) as well as whatever paperback book I 

am currently reading. The novels of Tolstoy, Hardy, Austen, 

Eliot, Dickens, Cervantes, James, Twain, Cather, 

Faulkner, Fitzgerald, Ellison, and many more have given 

me insight into the human condition and allowed me to 

experience aspects of life that I would never otherwise 

have understood. 

When I read news accounts about the war in Afghanistan, 

or the problems in Pakistan, or the now- turbulent 

and dangerous Arab Spring, or issues involving the children 

of British immigrants in London and their difficulties, 

I learn the answer to basic journalistic questions: 

who, where, when, what, and why. But I often turn to 

novels written by authors from these places to deepen 

my understanding. I want to know more than who is 

doing what to whom at a particular moment in time. If 

I don’t know much about the history and the culture as 

it has shaped the ways of thinking of those who live in 

the places discussed in the news, I won’t be able to truly 

fathom what is happening. 

I never fully grasped some of the tensions within Israel 

until I read books by Amos Oz. Nor did I understand 

apartheid as seen by Afrikaners and those resisting apartheid 

until I read the novels of Nadine Gordimer and Nelson 

Mandela’s autobiography. Milan Kundera and Joseph 

Skvorecky gave me fascinating glimpses of life in the 

Czech Republic under the communist regime. And I had 

an even better sense of the Czech world-view when I finished 

reading The Good Soldier Svejk by Jarislav Hasek, a 

comic tale of a hapless Czech soldier who was impressed 

into service in the Austrian army during World War I and 

forced to deal with the bureaucracy of an occupying regime. 

Robertson Davies, Mordecai Richler, Alice Munro, 

and Jane Urquhart taught me something about Canada. 

I learned about Germany in part through the novels of 

Gunter Grass, Thomas Mann, and Herta Muller. When 

Tip O’Neill said “All politics is local,” he might have also 

been talking the historic backdrop and cultural underpinnings 

that shape each of our world views. 

An understanding of the human condition as it exists 

in the many locales of our global world is essential for 

the twenty- first century lawyer, where clients, jurors, 

and judges are increasingly diverse. To be sure, the core 

principles of advocacy have not changed since the days 

of Cicero and Quintilian and Aristotle, whose works can 

still be studied for lessons in how to argue and present 

a case. Logical reasoning, the ability to evoke empathy, 

and a facility with words are as essential to outstanding 

advocacy today as when these classics were written. The 

advice to be gleaned from them remains as useful today 

as it was centuries ago when Cicero argued on behalf of 

his clients at trials in the Roman Forum. But advocates 

cannot follow this advice without a deep understanding 

of the world views of those from many different cultures. 

And however much the essential verities of advocacy 

and persuasion remain the same, the legal world is 

in the process of transformation in other ways as well. 

Naguib Mahfouz, an Egyptian author and winner of 

the Nobel Prize for Literature in 1988, said in one of his 

many books, “It seems to me as though there is no reality 

in the world except for change.” I agree. Although my 

professional life spans only a few decades, I can recall 

when the address for each letter—to a client or a court— 

had to be typed onto the envelope no matter how many 

On The Record, continued on page 6 

For The Defense ■ November 2012 ■ 1

DRI—The Voice 

of the Defense Bar 

Vol. 54, No. 11 November 2012 

President 

Mary Massaron Ross 

Detroit, Michigan 

Immediate Past President Henry M. Sneath 

Pittsburgh, Pennsylvania 

President-Elect 

1st Vice President 

2nd Vice President 

Secretary-Treasurer 

Executive Director 

J. Michael Weston 

Cedar Rapids, Iowa 

John Parker Sweeney 

Baltimore, Maryland 

Laura E. Proctor 

Nashville, Tennessee 

John E. Cuttino 

Columbia, South Carolina 

John R. Kouris 

Deputy Executive Director Tyler Howes 

Director of Publications 

Editor 

Production Manager 

Contributing Editor 

Advertising 

Representative 

Jay Ludlam 

Michelle Parrini 

Julia Bergerud 

Marge Motluck 

Laurie P. Mokry 

For The Defense, November 2012, Vol. 54, No. 11 (ISSN 

0015-6884). Copyright ©2012, DRI. All rights reserved. 

Published monthly by DRI, 55 West Monroe Street ~ 

Suite 2000, Chicago, Illinois 60603. Telephone: (312) 

795-1101. Fax: (312) 795-0747. 

Periodicals postage paid at Chicago, Illinois, and at 

additional mailing offices. Subscription price is $65.00 

per year, and, for DRI members, is included in the membership 

dues. Individual copies are $7.00 for DRI members 

and $12.00 for non-members, plus postage and 

handling. 

POSTMASTER: Send address changes to For The 

Defense, DRI, 55 West Monroe Street ~ Suite 2000, Chicago, 

Illinois 60603. 

Correspondence and manuscripts should be sent to 

the Editor. 

All views, opinions and conclusions expressed in this 

magazine are those of the authors, and do not necessarily 

reflect the opinion and/or policy of DRI and its 

leadership. 

In This Issue 

1 On The Record 

Embracing the Process of Transformation: DRI and the 21st Century Lawyer 

By Mary Massaron Ross, DRI President 

4 DRI News 

Members on the Move • DRI Calendar • DRI Congratulates 

New Officers and Board Members 

8 Affiliates in Action 

IDCA Honors Reynolds; Updates from AL, KS 

The Civil Justice System 

10 DRI’s Jury Preservation Task Force 

Ongoing Efforts to Preserve Our Unique Right 

By Jonathan M. Judge, Lori Vella and Hudson Jones 

Medical Liability and Health Care Law 

16 Medical Malpractice Defense 

The Role of the Nurse Paralegal 

By Robert C. Rouwenhorst 

Drug and Medical Device 

22 Fitting a Round Peg into a Square Hole 

FDA Off-Label Promotion Rules in the World of Social Media 

By Frederick H. Fern and Kelly E. Jones 

Product Liability 

28 From the Chair 

Making Great Greater 

By Charles A. Stewart III 

30 Asbestos Litigation 

Successor Liability and Current Trends 

By Tanya M. Lawson 

35 The Keys to Success 

Defending 30(b)(6) Depositions 

By Eric L. Probst 

42 Something for Nothing 

The Collateral Source Rule and 

Gratuitous Payments or Services 

By David M. Melancon and Kelly Brilleaux 

46 Conscious Pain and Suffering 

Carbon Monoxide Poisoning 

and Survival Damages 

By John F. Parker and Greg D. Wyles 

50 A Waivable Defect 

Current Application of the 

Forum Defendant Rule 

By Sara Deskins and Kathryn Isted 

56 Warnings and Instructions 

Answers to Some of My Favorite FAQs 

By Kenneth Ross 

62 The CDC Opens Pandora’s Box 

Federal Policy Change Could Unleash 

Lead Paint Poisoning Litigation 

By Paul S. Danner and William D. Wilson 

66 2.0 Is a Magic Number 

Yes It Is. It’s a Magic Number 

By Knight S. Anderson 

73 Be Armed with Good Science 

Defending Claims Against 

ROV Manufacturers 

By Douglas R. Morr and Gary J. Heydinger 

76 Writers’ Corner 

Let’s Try This Again: Motions for Reconsideration 

By Michael F. Smith 

78 Think Globally 

Another Step Forward: European-Style Class Actions 

By Dr. Thomas Rihm 

79 Defense Ethics and Professionalism 

An Entitlement of the Profession: The Pro Bono Call of Professionalism 

By Thomas A. Gilligan, Jr. 

83 Advocates and New Members 

2 ■ For The Defense ■ November 2012

DRI Services 

55 West Monroe Street 

Suite 2000 

Chicago, Illinois 60603 

Phone (312) 795-1101 

Fax (312) 795-0747 

Internet www.dri.org 

E-mail dri@dri.org 

Hours 

8:30-4:30 CST 

Monday-Friday 

DRI Staff Contacts (direct-dial 

numbers in area code 312). 

■ Membership Services 

■ Change of Address 

■ Group Life Insurance 

■ Disability and 

Major Medical 

■ Accidental Death 

and Dismemberment 

■ Professional Liability 

Insurance 

■ DRI Credit Card Program 

e-mail: membership@dri.org 

Cheryl Palombizio, 698-6207 

Marge Motluck, 698-6237 

Sarah M. Vlcek, 698-6258 

■ DRI Committees 

e-mail: committees@dri.org 

Lynn Conneen, 698-6221 

Char Graczyk, 698-6243 

■ Meeting Services 

Lisa M. Sykes, 698-6233 

Beth DeMars, 698-6234 

Sandra Galindo, 698-6254 

■ Annual Meeting 

e-mail: annualmeeting@ 

dri.org 

■ Advertising/ 

Marketing/Sponsorship/ 

Communications 

e-mail: marketing@dri.org 

Tim Kolly, 698-6220 

Katie Malinich, 698-6256 

Laurie P. Mokry, 698-6259 

Megan O’Neill, 698-6244 

Tracy Schorle, 698-6276 

■ Expert Witness Database 

■ DRI Online 

■ Website Content Mgmt 

e-mail: ewd@dri.org 

John Hovis, 698-6218 

■ For The Defense/In-House 

Defense Quarterly 

e-mail: jludlam@dri.org 

■ The Voice 

e-mail: thevoice@dri.org 

Barb Lowery, 698-6219 

■ Publication Orders 

e-mail: publ-orders@dri.org 

■ Seminars 

e-mail: seminars@dri.org 

Jennifer Cout, 698-6205 

Cathy Butler, 698-6226 

■ Webconferences/CLE 

Jamie Rocks, 698-6212 

■ Customer Service 

e-mail: custservice@dri.org 

Tiffany Caldwell, 698-6230 

Angelique Diaz-Rodriguez, 

698-6257 

Shnese Ingram, 698-6255 

DRI News 

4 ■ For The Defense ■ November 2012 

Members on the Move 

The law firm of Gallivan, White & Boyd, P.A., is 

pleased to announce the selection of H. Mills Gallivan 

and W. Howard Boyd, Jr., as “Lawyers of the 

Year” in their respective practice areas by Best Lawyers. 

Only a single lawyer in each practice area in 

each community is honored as the “Lawyer of the 

Year.” Mr. Gallivan was selected as 2013 Greenville 

Workers’ Compensation Law—Employers “Lawyer 

of the Year.” He has 36 years of experience as a 

civil defense trial attorney, mediator, and arbitrator. 

Mr. Gallivan is a past president of both the National 

Foundation for Judicial Excellence and the South 

Carolina Defense Trial Attorneys’ Association, and 

served as commissioner for the City of Greenville 

Planning Commission. Mr. Boyd was named 2013 

Greenville Product Liability Litigation—Defendants 

“Lawyer of the Year.” He has 35 years of experience 

successfully managing complex litigation for the 

firm’s clients and is perennially listed in Best Lawyers 

in America and in South Carolina Super Lawyers. 

Paul M. Lavelle, chair of the DRI Law Institute, is 

now the managing shareholder of Winstead PC’s new 

office in New Orleans. Shareholder Richard “Rick” 

Simses and of counsel Charles Miers and Jon Vicklund 

are working now in Winstead’s office in The 

Woodlands, Texas. All four lawyers handle energy, 

environmental, product liability, commercial litigation, 

insurance coverage and admiralty law. Tom 

Hutcheson, chair of Winstead’s energy and environmental 

law practice, says the group is a plus for the 

firm because Winstead has a number of clients who 

regularly do business in Louisiana or offshore Louisiana, 

and many Texas clients are involved in litigation 

in Louisiana. 

Butler, Snow, O’Mara, Stevens & Cannada PLLC 

(Butler Snow) attorney W. Neal McBrayer is a contributing 

author for the book Inside the Minds: 

Chapter 15 Bankruptcy Strategies. Mr. McBrayer is a 

member of the firm’s Commercial Litigation Group 

and Banking, Real Estate and Financial Services 

Group. He focuses his practice on bankruptcy, reorganization 

and creditors’ rights, financial services 

and transportation and logistics. “We are very 

proud of the hard work that has resulted in Neal’s 

inclusion in this book,” said Donald Clark, Jr., chair, 

Butler Snow. “His comprehension of the legalities 

associated with cross- border insolvencies is an asset 

to our firm, his practice group and certainly his clients.” 

Mr. McBrayer’s chapter in this book addresses 

U.S. recognition of foreign insolvency proceedings 

and seeking relief pending recognition. 

Reminger Co. LPA is pleased to announce that 

Suzanne Belot Norton of the firm’s Toledo, Ohio, 

office has recently been appointed Interim Law 

Director for the City of Maumee Law Department. A 

Workers’ Compensation Practice Group leader with 

Reminger, Ms. Norton is also workers’ compensation 

counsel for the City of Maumee. She has served as an 

assistant law director for the City of Maumee since 

2004. Licensed in Ohio, West Virginia, and Pennsylvania, 

Ms. Norton’s practice includes workers’ compensation 

defense for self- insured and state-funded 

employers, and representation of public employers 

and businesses in various aspects of municipal, governmental 

and employment practices law. “We are 

very proud of Suzanne’s…contributions thus far to 

the City of Maumee,” remarked Reminger Managing 

Partner Stephen E. Walters. 

Kurtis B. Reeg, president and managing partner 

of Reeg Lawyers LLC, a corporate litigation 

defense law firm headquartered in St. Louis, has been 

appointed to the arbitration and mediation panels 

at United States Arbitration & Mediation Midwest, 

Inc., the largest mediation and arbitration provider 

in the Midwest. 

Pittsburgh law firm Picadio Sneath Miller & Norton 

is pleased to announce that Alan S. Miller has 

been elected chair of the Board of Allegheny Land 

Trust (ALT), the preeminent land trust organiza- 

Members on the Move, continued on page 7 

Diversity and Inclusion in DRI: A Statement of Principle 

DRI is the largest international membership organization of attorneys defending the 

interests of business and individuals in civil litigation. 

Diversity is a core value at DRI. Indeed, diversity is fundamental to the success of the 

organization, and we seek out and embrace the innumerable benefits and contributions 

that the perspectives, backgrounds, cultures, and life experiences a diverse membership provides. 

Inclusiveness is the chief means to increase the diversity of DRI’s membership and leadership positions. DRI’s 

members and potential leaders are often also members and leaders of other defense organizations. Accordingly, 

DRI encourages all national, state, and local defense organizations to promote diversity and inclusion in their 

membership and leadership.

Calendar 

Upcoming events 

of interest to 

DRI members and 

other defense lawyers 

For more information 

about any of these events, 

call DRI Customer Service 

at (312) 795-1101, 

or visit our website at 

www.dri.org. 

November 29 Effectively Defending Rule 30(b)(6) Deponents in Bad Faith Cases Webcast 

December 6–7 Insurance Coverage and Practice Symposium New York City 

December 6–7 Professional Liability Seminar New York City 

2013 

January 8 Professional Liability 101: Insurance Producer Liability Webcast 

January 24–25 Fire Science and Litigation Seminar Scottsdale, AZ 

January 31– Civil Rights and Governmental Tort Liability Seminar 

Phoenix 

February 1 

February 5 Professional Liability 101: Insurance Coverage Webcast 

February 28– Toxic Torts and Environmental Law Seminar 

New Orleans 

March 1 

March 13–15 Women in the Law Seminar Miami Beach 

March 20–22 Trial Tactics Seminar Las Vegas 

March 21–22 Medical Liability and Health Care Law Seminar Miami Beach 

April 3–5 Product Liability Conference National Harbor, MD 

April 10–12 Insurance Coverage and Claims Institute Chicago 

April 24–26 Life, Health, Disability and ERISA Claims Seminar Boston 

May 1–3 Employment and Labor Law Seminar Phoenix 

May 9–10 Business Litigation Seminar Chicago 

May 9–10 Intellectual Property Seminar Chicago 

May 16–17 Drug and Medical Device Seminar New York City 

May 16–17 Retail and Hospitality Litigation and Claims Management Seminar Chicago 

May 30–31 Diversity for Success Seminar Chicago 

DRI Calendar 

Investigative Technologies Inc. 

TM 

Forensic Engineering • Expert Testimony 

Accident Reconstruction 

AreAs of expertise: 

• Biomechanical 

• Civil/structural 

• Construction 

• Consumer products 

• Disaster 

• electrical 

engineering 

• environmental 

engineering 

• fire investigation 

• Human factors 

• industrial Machinery 

• Marine 

• Material sciences 

• Mold 

• safety/osHA 

Compliance 

• slip & fall 

• Vehicular 

Visit us online: 

• search periodicals 

• immediate online help 

• View expert profiles 

• press room of events 

www.cedtechnologies.com 1-800-780-4221 

Washington • Cleveland • Jacksonville • New York • Ft. Lauderdale • Chicago 



On The Record, from page 1 

times that client or court had been written 

to before, and when multiple copies of 

documents were made by carbon paper or a 

mimeograph machine. Not so long ago, the 

distances on our globe seemed much farther 

apart; no Internet allowed us to correspond 

instantaneously; no Skype could 

visually connect us; and the expense of air 

travel was largely prohibitive. 

Lawyers, law firms, corporations, and 

insurance companies face these and other 

changes. Technology is changing at an 

accelerating rate, requiring alteration of 

fundamental business processes. Newspapers, 

blogs, and magazines recount the rise 

of enormously expensive e- discovery, the 

problems created by class actions, and the 

diminished role that jury trials have in resolving 

disputes. In addition, today’s world 

is increasingly global, which means that our 

clients are often engaged in litigation across 

national borders, which adds to the complexity 

of the practice of law and requires 

lawyers to learn new skills. In a highly competitive 

world, lawyers must cope with increasingly 

vehement demands for value 

and efficiency. To cope, lawyers must learn 

more effective ways of budgeting and project 

management than in the past. 

Dwight D. Eisenhower, an underrated 

former president of the United States and 

a favorite of mine, once said, “Neither a 

wise man nor a brave man lies down on 

the tracks of history to wait for the train 

of the future to run over him.” His aphorism 

underscores the need to be continually 

forward- looking, and warns of the consequences 

of failing to do so. That is why the 

theme of the just-past 2012 DRI Annual 

Meeting was “The 21st Century Lawyer.” After 

a decade in this new century, we sought 

to bring you an in-depth dive into practice 

for the future. Sessions dealt with the global 

economy and politics, communicating effectively 

to an increasingly diverse audience, 

resolving high-stakes litigation, the 

twenty- first century pattern products litigation, 

arbitration, the maze of social media, 

twenty- first century leadership from a new 

generation of general counsel, the specter of 

increasing litigation in Europe and how to 

coordinate global litigation, and numerous 

other cutting edge topics. 

But an Annual Meeting focus is not 

enough. Niccolo Machiavelli warned that 

“[w]hosoever desires constant success 

must change his conduct with the times.” 

While Machiavelli is disliked by many for 

his approach to the use of power, he was 

unquestionably a brilliant strategist and we 

should all pay heed to his advice on changing 

with the times, advice echoed more 

recently by the folk troubadour, Bob Dylan, 

in his 60s classic, “The Times They Are 

A- Changing.” With this in mind, we have 

undertaken three initiatives for this coming 

year. First, we have appointed a task 

force to follow up on the theme of “The 21st 

Century Lawyer.” The task force will examine 

this topic with a goal of developing specific 

training designed to equip lawyers to 

thrive in this new world. Second, and consistent 

with our long- standing efforts to 

provide the most current and best continuing 

legal education for our members, DRI 

will hold a global arbitration summit next 

June in Prague that will focus on the world 

of arbitration, historically of great importance 

in many European countries and of 

increasing importance in the United States 

and other parts of the world. This summit 

will bring together the leading experts in 

arbitration from various arbitral seats to 

discuss what is happening in the world of 

arbitration, and what skills and experience 

clients will be looking for in future lawyers. 

We expect the discussions at this summit 

to inform us further about the educational 

needs for lawyers in the future. Third, DRI 

is examining the training needs of its corporate 

and insurance industry members to 

see how it can be of service at a time when 

funds available for internal training of 

insurance company adjusters and personnel 

and in-house lawyers in a corporate setting 

has decreased. 

DRI has existed for over 50 years, and 

during that time has constantly sought to 

be faithful to its mission while changing 

its programs as the needs of its members 

change. These efforts will, I hope, continue 

in that long tradition. I am proud to serve 

as your president, and to work with you on 

these and other initiatives in the coming 

year. Please do not hesitate to call me to discuss 

any of your thoughts and ideas as the 

year continues. 

Need a 

new logo 

for your bio 

and firm 

website 

1 

3 

2 

Contact Tracy Schorle at tschorle@dri.org or 312.698.6276. 



DRI Congratulates New Officers and Board Members 

Last month at the DRI 

Annual Meeting in New 

Orleans, the organization 

welcomed its new 

leaders, including President 

Mary Massaron 

Ross of Plunkett Cooney 

PC, in Bloomfield Hills, 

Michigan. Ms. Massaron 

Ross, just the second 

woman to lead DRI, 

takes the reins from Henry M. Sneath of Picadio Sneath Miller & 

Norton, P.C., in Pittsburgh, who will continue his service, now as 

immediate past president. J. Michael Weston of Lederer Weston 

Craig PLC in Cedar Rapids, Iowa, is now president- elect and John 

Parker Sweeney of Womble Carlyle Sandridge & Rice PLLC in 

Baltimore rises to the office of first vice president. Joining 

Mr. Weston and Mr. Sweeney on the track to the DRI presidency 

will be Laura E. Proctor of LP Building Products in 

Nashville, Tennessee, who was elected by the DRI Board 

of Directors to serve as second vice president. In 2015, Ms. 

Proctor will become the third woman president of DRI, and 

the first in-house counsel to hold the office. Congratulations 

are extended as well to new officer John E. Cuttino of Turner 

Padget Graham & Laney PA in Columbia, South Carolina, 

Mary Massaron Ross, Henry M. Sneath, J. Michael Weston, John Parker Sweeney, Laura E. Proctor and John E. Cuttino 

who was selected to serve the organization as secretarytreasurer, 

and to eight new members of the DRI Board of Directors. 

In New Orleans, four individuals were elected by the 

board to join them as national directors: Kathleen M. Guilfoyle 

of Campbell Campbell Edwards & Conroy PC in Boston; 

Jack B. “Skip” McCowan, Jr., of Gordon & Rees LLP in 

San Francisco; William F. Ray of Watkins & Eager PLLC in 

Jackson, Mississippi; and Scott Burnett Smith of Bradley 

Arant Boult Cummings LLP in Huntsville, Alabama. In addition 

to the national directors, four new regional directors 

were elected earlier this year: Michael J. Leegan of Goldberg 

Segalla LLP in Princeton, New Jersey (Atlantic Region); 

Thomas R. Schultz of Schultz & Pogue LLP in Indianapolis 

(North Central Region); C. Douglas Dooley of Leitner, 

Williams, Dooley & Napolitan PLLC in Chattanooga, Tennessee 

(Southern Region); and Mark J. Neal of the Neal Law Firm in Monroe, 

Louisiana (Southwest Region). More coverage of the 2012 DRI 

Annual Meeting will be published in the December 2012 issue of 

For The Defense. 

Kathleen M. Guilfoyle, Jack B. “Skip” McCowan, Jr., William F. Ray and Scott 

Burnett Smith 

Michael J. Leegan, Thomas R. Schultz, C. Douglas Dooley and Mark J. Neal 

Members on the Move, from page 4 

tion for Allegheny County and its environs. 

Mr. Miller has served on the board 

of ALT for the past eight years, and is honored 

to lead the board of directors of this 

important land trust nonprofit organization 

and to work closely with ALT’s new 

executive director, Chris Beichner. Mr. 

Miller’s service as board member and now 

chair continues the firm’s long connection 

with ALT; Anthony P. Picadio was one 

of the founding members of ALT, having 

guided the inception and early growth of 

the organization. 

David L. Taylor, formerly of Jennings, 

Taylor, Wheeler & Haley in Carmel, Indiana, 

has opened his own practice, the Taylor 

Law Firm in Indianapolis. Mr. Taylor 

will continue to focus his practice on insurance 

coverage, insurance defense, environmental 

law, and general litigation. Mr. 

Taylor was recently named one of Indiana’s 

Top Lawyers by the Wall Street Journal. 

Kolesar & Leatham, one of Nevada’s 

largest independent law firms, announces 

that Scott R. Cook has joined the firm as a 

shareholder focusing on civil litigation. Mr. 

Cook’s expertise expands the depth of the 

firm’s capabilities in complex civil litigation, 

catastrophic injury, and representation of 

medical professionals and institutions. Mr. 

Cook brings more than 30 years of experience 

to the firm. He is admitted and actively 

practicing in Nevada, Arizona, Colorado, 

Nebraska, and New Mexico. 

Marge Motluck 


Alabama 

Affiliates in Action 

IDCA Honors Reynolds; Updates from AL, KS 

The annual meeting of the Alabama 

Defense Lawyers Association (ADLA) 

was held June 14–17, 2012, at the Sandestin 

Golf & Beach Resort with outgoing 

president David K. Howard 

of Florence presiding. At the 

annual business meeting of the 

members on June 16, the election 

process resulted in the following 

slate of new Officers and 

Board Members: 

• Melody H. Eagan of Birmingham, 

President 

• Joseph J. “Jay” Minus, Jr. of 

Mobile, President-Elect 

• W. Dudley Motlow, 

Jr. of Birmingham, 

Secretary-Treasurer 

• Gary K. Grace of Huntsville, 

District I Director 

• Christie J. Strange of Birmingham, 

District II 

Director 

• Robert C. Ward, Jr. of Montgomery, 

District III Director 

• Ricardo A. Woods of Mobile, 

District IV Director 

• John P. Browning of Mobile, President—Young 

Lawyers’ Section 


Melody H. Eagan 

Joseph J. “Jay” 

Minus, Jr. 

Iowa 

Member Kevin M. Reynolds was awarded 

the Ed Seitzinger Award by the Iowa 

Defense Counsel Association (IDCA) at its 

annual meeting and dinner on September 

13, 2012. This honor is bestowed annually 

on the IDCA member who has contributed 

the most to the organization over the past 

year. Mr. Seitzinger, for whom the award 

is named, was in-house counsel for Farm 

Bureau Insurance Company. He was one 

of the founders and first presidents of the 

IDCA when it was formed in 1969. 

Whitfield & Eddy has had a close relationship 

with the IDCA from 

its inception. Firm members 

David Phipps, Jaki Samuelson, 

and Megan Antenucci are all former 

presidents of the IDCA. Mr. 

Reynolds was also appointed to 

the IDCA Board of Directors and 

will be serving in that capacity 

during 2012–2013. The IDCA is 

the largest association of lawyers 

in Iowa who are committed 

to the pursuit of justice and 

the representation of defendants 

in litigation. It is one of the oldest 

and most active state defense 

organizations in the United 

States. 

As a product liability defense 

attorney, Mr. Reynolds has tried 

dozens of cases to jury verdict 

in state and federal courts for 

over 30 years. He is 

sensitive to the needs 

of self- insured manufacturers 

and insurers who 

underwrite these unique risks, 

and has represented wholesalers, 

distributors, and retailers 

in product cases as well. He is 

intimately familiar with such 

issues as product recalls; conducting 

evidentiary Daubert 

hearings in federal court; spoliation 

of evidence; defenses based on federal 

preemption; protective orders against 

the dissemination of internal, confidential, 

and proprietary trade- secret type design 

information; and keeping proof of other 

accidents, claims or lawsuits out of evidence. 

Mr. Reynolds is also an experienced 

instrument- rated private pilot, with over 

1,700 flight hours since 1989. His flying 

experience gives him a distinct advantage 

when he works on aviation- related matters. 

His extensive jury trial, litigation and 

appellate- court experience provides him 

with a solid background when litigating 

commercial cases. Mr. Reynolds is a past 

Kevin M. Reynolds 

chair of the DRI Product Liability Committee 

and a current member of its steering 

committee. 

Kansas 

The Kansas Association of Defense Counsel 

(KADC) annual conference is set for 

December 7–8, 2012, at the Marriott 

Country Club Plaza in Kansas City, Missouri. 

Highlights this year include Kansas 

Supreme Court Justice Dan Biles, a 

highly entertaining presentation by Malcolm 

Kushner on persuasiveness and use 

of humor to make your point, illustrated 

by video clips of U.S. Presidents, a panel 

discussion led by USDC Magistrate Judge 

David Waxse and Johnson County Judge 

David Hauber on electronic discovery in 

federal and state court, and Steve Kerwick 

and Sarah Warner’s ever- popular case law 

update. In conjunction with the annual 

meeting, the KADC will again hold a trial 

skills workshop on December 6, which will 

focus on cross examination of the plaintiff 

and plaintiff’s expert witness. A full year’s 

worth of CLE credits, including 

two hours of ethics, are available 

at this single conference, 

where you can also mingle with 

colleagues, network with clients 

and enjoy all the Plaza has to 

offer during the holidays. Registration 

and additional information 

is available at http://www. 

kadc.org/. 

In other news, in an effort to 

bolster membership, the KADC 

Board of Directors recently adopted new 

membership incentives, as follows: 

• Lawyers admitted to the bar five years or 

less who join KADC will receive one free 

registration to the annual conference in 

their first year of KADC membership (a 

value of up to $410). 

• Lawyers who are members of DRI, but 

who have never been a KADC member, 

will receive a free one-year membership 

in KADC (a value of up to $190). 

• Law students who are members of 

KADC will receive free registration to 

the annual conference while they are full 

time students.

Download the Apps 

Search the Apple store for 

DRI events and DRI The 

Voice of the Defense Bar


DRI’s Jury Preservation 

Task Force 

By Jonathan M. Judge, 

Lori Vella 

and Hudson Jones 

Ongoing Efforts 

to Preserve Our 

Unique Right 

A review of the factors 

behind the vanishing 

jury trial, and a look at 

how some jurisdictions 

are implementing 

innovations designed to 

address the problem. 

The problem of the vanishing jury trial is a familiar one 

to DRI members, for whom this loss is keenly felt. This 

decline in jury trials presents not only an economic threat 

to membership, but also a decline in fair and just adjudication. 

Many disputes cannot and should 

not settle, and contrary to what mediators 

frequently claim, the fact that everyone is 

dissatisfied with a settlement is not necessarily 

proof that settlement was the appropriate 

resolution. 

■ Jonathan M. Judge, a partner of Schiff Hardin LLP in Chicago, focuses his practice on product 

liability and related litigation. He is the publications chair for the DRI Trial Tactics Committee. 

Lori Vella is a partner at Butler Pappas in Tampa, specializing in complex property 

contractual disputes and extra- contractual claims, as well as litigation involving construction 

defects and professional liability. She serves DRI as membership chair of the Insurance 

Law Committee and as a member of the Jury Preservation Task Force. Hudson 

Jones is an associate at Butler Pappas in Tampa, working in the firm’s Property Coverage 

Group. 


While juries take their fair share of criticism, 

most lawyers recognize that juries 

typically try hard and generally do a good 

job. Juries are also often more defensefriendly 

or at least neutral than commonly 

perceived. And defense lawyers routinely 

have more confidence in a jury to resolve 

disputes fairly than the assigned judge, 

whether that jurist is appointed or elected. 

With the establishment of the Jury Preservation 

Task Force (JPTF), DRI has joined 

the nationwide effort to revive the civil jury 

trial as a primary means of resolving disputes. 

This article presents an overview of 

the jury trial’s decline, a survey of existing 

perceptions among membership, an introduction 

to some innovations occurring in 

certain jurisdictions, and a brief summary 

of DRI’s upcoming efforts. 

History of Jury Trials 

in Civil Matters 

A trial by jury has been described 

as one of the most effective weapons 

in democracy’s arsenal to combat 

tyranny. Stanley E. Sacks, Preservation 

of the Civil Jury System, 22 Wash. 

& Lee L. Rev. 76 (1965). Jury trials are 

a “bulwark of liberty and a cornerstone 

of democracy.” Id. Thomas Jefferson 

strongly characterized the trial by 

jury “as the only anchor yet imagined by 

man, by which a government can be held 

accountable to the principles of its constitution.” 

3 The Writings of Thomas Jefferson 

71 (Washington ed. 1861). America’s 

jury trial system has long been admired 

because of its unique role in holding both 

the government and its citizens accountable. 

The French statesmen, Alexis de Tocqueville, 

following a visit to the United 

States, captured the empowering concept 

of this sacred American ideal in a single 

sentence. “The institution of the jury places 

the real direction of society in the hands of 

the governed and not in that of the government.” 

Alexis de Tocqueville, Democracy In 

America, 282–83 (1835). 

The Seventh Amendment codifies the 

right to a jury trial in civil cases. It was 

part of the original Bill of Rights adopted 

by Congress on September 25, 1789, and 

ratified by the states on December 15, 1791. 

The amendment states, “In Suits at common 

law, where the value in controversy shall 

exceed twenty dollars, the right of trial by 

jury shall be preserved, and no fact tried 

by a jury, shall be otherwise re- examined 

in any Court of the United States, than according 

to the rules of the common law.” A 

civil jury acts as a moral arbiter and legal 

fact-finder. Some of the virtues of the civil 

jury include 1) keeping the law in touch 

with popular values; 2) serving as a guard 

against excessive rigidity in the law; 3) independence; 

4) the symbolic value of rule by 

the people; 5) the advantage of numbers in 

decision- making; 6) the expertise ordinary 

people bring; 7) providing judges political 

cover for unpopular decisions; 8) educating 

people about the law through jury service; 

and 9) the greater drama a jury trial brings 

to the administration of justice. Mark P. 

Gergen, The Jury’s Role in Deciding Normative 

Issues in the American Common Law, 68 

Fordham L. Rev. 407, 436–37 (1999). 

Why Are Civil Jury Trials Vanishing 

For the last 50 years, the number of jury 

trials conducted annually has sharply declined. 

Margo Schlanger, What We Know 

and What We Should Know About American 

Trial Trends, 2006 J. Disp. Resol. 35, 36– 

37; Marc Galanter & Angela Frozena, The 

Continuing Decline of Civil Trials in American 

Courts, 2011 Pound Civil Justice Inst. 

Federal civil cases resolved by trial fell from 

11.5 percent in 1962 to 1.8 percent by 2002. 

Marc Galanter, The Vanishing Trial: An Examination 

of Trials and Related Matters in 

Federal and State Courts, 1 J. of Empirical 

Legal Studies 459 (2004). The even steeper 

drop in bench trials suggests that the downward 

trend in jury trials is due to an overall 

decline in the number of cases that reach 

the trial phase of litigation. Civil jury trials 

in state courts have experienced an unprecedented 

decline similar to their federal 

court counterparts. One particular study 

of 22 states concluded that there were only 

13 jury trials for every 1,000 civil dispositions, 

a meager 1.3 percent. Brian J. Ostrom, 

Shauna Strickland & Paul Hannaford, Examining 

Trial Trends in State Courts: 1976– 

2002, 1 J. Empirical Legal Stud. 755 (2004). 

Several theories have been advanced to explain 

the drastic shift away from trials. 

The Usual Suspects 

Many reasons for the decline in jury trials 

have been discussed at length, and do not 

need extensive review. The increased cost 

of going to trial due to longer and more 

complex cases has rightly taken a share of 

the blame for the obvious decline in trials. 

Marc Galanter, The Vanishing Trial: An 

Examination of Trials and Related Matters 

in Federal and State Courts, 1 J. of Empirical 

Legal Studies 459, 477–81 (2004). Also, 

an increase in the number of cases settling 

to avoid the economic burden and risk of 

going to trial accounts for a substantial 

portion of cases terminating before trial. 

When parties are unable to settle prior to 

court involvement, increased judicial management 

frequently steers parties to nevertheless 

resolve their disputes without trial. 

Marc Galanter, The Hundred- Year Decline 

of Trials and the Thirty Years War, 57 Stan. 

L. Rev. 1255, 1265 (2005) (providing that 

federal judges increasingly spend their 

time encouraging parties to settle before 

trial). Additionally, ADR programs dispose 

of a significant number of claims, making 

trial unnecessary. The American Arbitration 

Association reported an increase in 

filings from 1,000 to over 17,000 between 

1960 and 2002. Finally, judges utilize summary 

judgment to dispose of cases without 

trial more today than in previous decades. 

Richard L. Steagall, The Recent Explosion 

in Summary Judgments Entered by the Federal 

Courts Has Eliminated the Jury from 

the Judicial Power, 33 S. Ill. U. L.J. 469, 469 

(2009); William G. Young, Vanishing Trials, 

Vanishing Juries, Vanishing Constitution, 

40 Suffolk U. L. Rev. 67, 78 (2006). 

The Innocent Bystander 

Longer and more elaborate trials, additional 

procedural hurdles, and budget cuts 

invite casual observers to conclude that the 

decline in jury trials is due to a lack of judicial 

resources. There is no question that our 

nation’s courts are in many respects underfunded. 

Increasing court funding will be 

necessary to support and strengthen our 

civil courts. Some observers and scholars 

have taken the view that the decline in civil 

jury trials is often incorrectly attributed to 

resource constraints. The data this argument 

relies upon suggests that rather than 

insufficient resources to conduct additional 

trials, the real story is the judiciary’s reallocation 

of its resources to pretrial judicial 

management. 

As Professor Marc Galanter has explained, 

three trends suggest that the ju- 



A trial by juryhas been 

described as one of the 

most effective weapons 

in democracy’s arsenal 

to combat tyranny. 

diciary has the resources to conduct more 

trials but that these resources are primarily 

allocated to case management instead. 

First, federal judicial resources greatly increased 

between 1962 and 2002. The number 

of district court judges rose from 279 to 

614 in this time period. Similarly, the number 

of nonjudicial personnel employed by 

the judiciary increased from 5,602 to almost 

26,000 between 1962 and 1992 (the 

last year that data was available). Furthermore, 

judicial expenditures (accounting for 

inflation) increased from roughly $2.5 million 

to $4.25 billion between 1962 and 2002. 

Second, federal district court judges conducted 

fewer than half as many trials in the 

early 2000s as they did in the 1980s. Third, 

the number of filings per Article III judge 

more than doubled between 1962 and 2002. 

Galanter, The Vanishing Trial at 500–501. 

Approximately 20 percent of cases filed in 

1963 resolved “before pretrial” due to managerial 

judges steering parties towards settlement; 

in 2010, roughly 70 percent of cases 

terminated “before pretrial” due to judicial 

management. Galanter & Frozena, The Continuing 

Decline of Civil Trials in American 

Courts at 20 fig. 16. Indeed, federal judges 

presided over an average of 40 trials annually 

in the “era before the arrival of ‘managerial 

judging’” and only an average of 10 

per year since this ideological shift. 

Whether judges could adequately adjudicate 

the cases on their dockets if they 

allocated fewer resources to judicial management 

and spent more time conducting 

trials is an open question. Some statistics 

suggest the percentage of cases terminating 

with no court involvement decreased 

significantly between 1963 and 2010 from 

approximately 55 percent of all filings 

to roughly 18 percent. Cases terminated 


“before pretrial” due to judicial management 

largely displaced cases resolved 

without judicial involvement, while the 

number of cases reaching the pretrial stage 

remained fairly constant. This suggests 

that there are some cases that would likely 

settle without the investment of judicial 

resources. More data is needed to confirm 

such generalized trends. However, to preserve 

civil jury trials in the future, scholars 

and practitioners alike should recognize 

and balance the need for more judicial 

funding to help bolster the ideal that jury 

trials are important and must remain an 

integral part of the legal process. 

Surprising Culprits 

Although prisoner litigation has not 

received much attention in the scholarship 

on the decline in civil juries, it is a 

significant cause of the decrease in trials. 

The Prison Litigation Reform Act of 

1995 (PLRA) was enacted in response to 

an increase in prisoner litigation in federal 

courts. By increasing the number and 

complexity of procedural requirements, as 

well as decreasing the potential remedies 

available to prisoners, the PLRA significantly 

decreased the number of prisoner 

filings and trials. At their peak, prisoners’ 

suits constituted one-sixth of all trials in 

1996 and declined to roughly one-eighth of 

all trials by 2002. Over a third of all prisoners’ 

trials were before juries prior to the 

PLRA. Thus, the decline in prisoners’ suits 

accounts for a substantial decline in the 

number of jury trials. 

The cyclical nature of the decline in civil 

jury trials may also largely explain their 

demise. As summary judgment motions, 

ADR, settlements, and other forms of resolution 

replace trials, fewer lawyers and 

judges have trial experience. For attorneys, 

lack of trial experience adds to their perception 

that trials are risky and that juries 

are arbitrary and “out of control.” Galanter 

& Frozena, The Continuing Decline of Civil 

Trials in American Courts at 23; Galanter, 

The Vanishing Trial at 517–18. Attorneys’ 

view that trials are unpredictable discourages 

them from taking future cases to 

trial; and therefore, attorneys continue to 

lack trial experience. Judges are also inundated 

with ideological rhetoric that trials 

are wasteful. Galanter, The Hundred- Year 

Decline of Trials and the Thirty Years War 

at 1266. As trial judges manage more cases 

to settlement, steer an increasing number 

of disputes to some form of ADR, and 

decide more cases on motions for summary 

judgment, trials may seem more 

wasteful because judges lack the breadth of 

trial experience necessary to conduct trials 

efficiently. An interesting future research 

question would be whether district court 

judges are actually less efficient at conducting 

trials than in previous decades. The 

increase in judges’ dockets and case management 

expectations may have made them 

more efficient in all areas of their job, including 

conducting actual jury trials. However, 

until these perceptions about the risks 

and inefficiencies of trials are changed or 

there are more incentives for taking cases 

to trial, the decline in jury trials will continue 

to have a cyclical effect that perpetuates 

the downward trend. 

SLDO Surveys and State 

Reform Measures 

The “usual suspects” and “innocent 

bystander” factors outlined in the previous 

section are consistent with recent surveys 

by the JPTF directed to state and local 

defense organizations (SLDOs). Leading 

defense attorneys were asked to complete a 

formal questionnaire regarding what they 

perceived as the most significant issues 

impacting civil jury trials in their respective 

states. While the responses varied 

state-to-state, the “usual suspects” and 

“innocent bystander” factors were all present 

and noted as reasons why jury trials 

are vanishing. JPTF, SLDO Survey, Update: 

March 22, 2012. Modern ADR, mandatory 

mediation and arbitration, increased discovery 

and pretrial defense costs, court 

system budget cuts, and tort reform were 

the most prevalent responses to the survey. 

The omnipresent emphasis on ADR in 

most states has caused the attention to shift 

away from trials. Ironically, and unfortunately, 

many have forgotten that “trial, and 

particularly trial by jury, is the least-used 

dispute resolution methodology in America.” 

David A. Domina and Brian E. Jorde, 

Trial: The Real Alternative Dispute Resolution 

Method, Voir Dire Fall/Winter 2010. 

However, regardless of the multiple causes, 

the SLDO survey respondents overwhelmingly 

state that civil jury trials are indeed 

vanishing in their states.

One of the most important aspects confirmed 

by the SLDO survey is that not much 

is being done through state reforms to 

change this civil jury trial decline. Vanishing 

trial theories and empirical data have 

been far too focused with the “cause” of the 

decline, and less focused on actual “solutions” 

that could serve to dispel these commonly 

cited reasons for the decline. This 

lack of focus is evident in one of the crucial 

follow- up questions contained within 

the SLDO survey. When asked whether 

their states have undertaken any actions 

to increase the number of civil jury trials 

at any level, respondents of the survey 

overwhelmingly stated “No.” The obvious 

rhetorical question is: Why not If legal 

scholars and practitioners already know 

the causal roots of the problem, why are 

there only very minimal reform efforts at 

the state and federal levels to fix the obvious 

decline in jury trials 

Perhaps there should be more focus on 

proactive reforms, and less focus on empirical 

data showing a decline that all seem 

to acknowledge already exists. Undoubtedly, 

most tend to agree with the reasons 

for the decline in civil jury trials. However, 

very few know how to solve or improve the 

decline problem. It is unlikely that there is 

one universal “silver bullet” reform measure 

that will cure the increased decline 

in civil jury trials. After recognizing that 

there is definitely a serious problem generally, 

some states have chosen to take action 

by implementing reform measures to 

address some of the specific problems that 

either cause or contribute to the decline in 

civil jury trials. 

Ideas for reform have come from various 

sources, but many states point to a 

report by the American College of Trial 

Lawyers (ACTL) and the Institute for the 

Advancement of the American Legal System 

(IAALS) as the impetus for their 

proposals. See Pilot Project Rules, Institute 

for the Advancement of the American 

Legal System (Nov. 2009). At the 2011 

National Jury Summit, IAALS outlined 

its call to action, issuing a report that outlined 

the jury trial decline and discussed 

several ways the individual states could 

institute reform projects and help solve 

the problem. 

The premise of IAALS’s call to action 

rested on a simple theory: “Litigants in 

unacceptable numbers are being priced 

out of the civil justice system and priced 

out of trial by jury.” The factors at the top 

of the list causing the problem were “cost” 

and “delay,” the empirical buzzwords for 

“too expensive and not worth it to litigate.” 

The focus of the IAALS and ACTL reports 

underscore the importance of three common 

reform initiatives: (1) proportional 

discovery, (2) fact- pleading requirements, 

and (3) expedited trials and categorical 

trial procedures. Both through voluntary 

pilot programs and mandatory changes to 

the rules of the courts, these programs and 

proposals are already impacting the civil 

justice system in state and federal courts 

across the country. 

Here are some innovations of interest. 

Utah’s Three-Tier Approach and Changes 

to the Rules of Civil Procedure 

How many times have we seen cases settle, 

and trial therefore avoided, simply because 

the cost of discovery has proved too enormous 

in the years leading up to trial How 

many cases that should have been tried 

settled because parties poured all their 

resources into costly pretrial discovery and 

eventually spent all their money conducting 

discovery, taking hours of depositions, 

and jockeying over insufficient interrogatory 

answers and incomplete document 

production In 2011, Utah attacked one of 

the “usual suspects” causing a decline in 

jury trials by proposing several amendments 

to the Utah Rules of Civil Procedure 

that would help eliminate unnecessary 

costs associated with discovery. The Utah 

Supreme Court approved a number of these 

substantial amendments in an effort to 

get back to the primary purpose of the 

Rules of Civil Procedure—to achieve the 

just, speedy, and inexpensive determination 

of every action. Federal Civil Procedure 

Rule 1 provides that the rules “should 

be construed and administered to secure 

the just, speedy, and inexpensive determination 

of every action and proceeding.” 

Similarly, most state civil procedure rules 

also contain similar “purpose” language. 

These substantial amendment changes 

limit parties to discovery that is proportional 

to the stakes of the litigation, curb 

excessive expert discovery, and require 

the early disclosure of documents, witnesses, 

and evidence that a party intends to 

The increased cost 

of going to trial due to 

longer and more complex 

cases has rightly taken a 

share of the blame for the 

obvious decline in trials. 

offer in its case-in-chief. The amendments 

became effective for all cases filed on or 

after November 1, 2011. 

Utah’s new rules attack the problem of 

unnecessary, prolonged, and costly discovery 

by adopting a proportional three-tier 

approach. The tiers set limits for standard 

fact discovery and prevent a party from 

running up discovery costs unnecessarily 

before trial. The rule also sets a discovery 

cut-off to expedite the case. At least in 

Utah, no longer will a party be able to conduct 

years of costly discovery before trial. 

In the event that a party claims damages, 

but does not plead an actual amount, the 

party must still plead that their damages 

are such as to qualify for a specified tier. 

The three tiers are: 

• Tier 1 = Under $50,000; Three hours of 

fact witness depositions; no interrogatories; 

five requests for production; five 

request for admissions; 120 days to complete 

standard discovery. 

• Tier 2 = $50,000–$299,000 and actions 

for non- monetary relief: 15 hours of 

fact depositions; 10 interrogatories; 

10 requests for production; 10 request 

for admission; 180 days to complete 


• Tier 3 = $300,000 and above: 30 hours 

in fact depositions; 20 interrogatories; 

20 requests for production; 20 request 

for admission; 210 days to complete 


To obtain discovery beyond these limits 

the parties may stipulate that extraordinary 

discover is necessary and proportional. 

However, each party must review and 

approve a discovery budget. A party may 

also file a motion for extraordinary dis- 



covery under similar guidelines. Any stipulation 

or motion must be filed before the 

close of standard discovery and after reaching 

the limits. See U.R.C.P. 26(c). 

The party seeking discovery always has 

the burden of showing proportionality and 

relevance. Most importantly, the proportional 

three-tier approach allows a court to 

order that the requesting party bear some 

If legal scholarsand 

practitioners already 

know the causal roots 

of the problem, why 

are there only very 

minimal reform efforts 

at the state and federal 

levels to fix the obvious 

decline in jury trials 

or all of the costs of producing the information 

to achieve proportionality. Imagine 

how many attorneys would choose to conduct 

a “fishing expedition” if they had to 

pay for and bear the expense of all the voluminous 

and costly information produced. 

It is too early to predict whether Utah’s new 

three-tier system will help avoid the discovery 

problems inherently related to the 

decline in civil jury trials. However, the 

new rules are a bold and appropriate step 

in the right direction because they tend to 

reduce and limit unnecessary discovery 

costs that could be allocated for trial. 


California’s Expedited Jury Trials Act 

California is focused on reforming the 

delays and costs associated with civil jury 

trials and passed a bill focused on expediting 

jury trials and reducing the costs associated 

with trial. On January 1, 2011, the 

California state legislature unanimously 

passed Assembly Bill 2284, known as the 

Expedited Jury Trials Act. The bill was 

introduced by Assembly member Noreen 

Evans (D-Santa Rosa), a former trial 

lawyer. This trial reform bill significantly 

speeds up the opportunity for parties to 

receive a trial, especially for smaller cases 

that otherwise would not likely go all the 

way to trial. However, each party must 

agree to the expedited trial process. 

California’s Expedited Jury Trials Act 

has several unique and key features. First, 

the entire trial—from voir dire to closing 

arguments—occurs in one day. Each 

side must agree to present its entire case in 

three hours, including cross- examination 

of the other side’s witnesses. This time limitation 

eliminates all extraneous information 

that is less necessary to the case and 

likely unnecessary for the jury to reach a 

verdict. The limitation forces both sides to 

simplify their cases to the material issues 

at hand. Second, the standard rules of evidence 

still apply, but the parties waive any 

rights to appeal or make posttrial motions. 

All evidentiary objections are handled 

during a pretrial conference, eliminating 

potential delays during trial. Without 

the right to appeal, the parties essentially 

have to be extremely confident with their 

cases because there is no “second bite at 

the apple” if things do not go your way. 

Third, the juries are smaller and consist 

of eight people with two alternates. Three 

peremptory challenges are permitted for 

each side. Fourth, all witness lists, exhibits, 

and other materials would be exchanged 25 

days before trial. Lastly, the two sides are 

required to reach a “high/low agreement” 

related to the minimum and maximum 

amount of damages. The minimum and 

maximum amounts would control regardless 

of the jury’s verdict. 

When the Expedited Jury Trials Act was 

proposed and signed into law, commentators 

suggested that the reform measure 

found praise from plaintiff and defense 

bars alike. American Association for Justice, 

California lawmakers vote to allow 

expedited jury trials, September 23, 2010 

at http://www.justice.org/cps/rde/xchg/justice/ 

hs.xsl/13351.htm. However, whether this particular 

measure will actually increase the 

number of civil jury trials is less certain. 

It will likely take several years to evaluate 

if the measure is truly working. However, 

like Utah’s three-tier approach to limit discovery, 

California’s Expedited Jury Trials 

Act may in time prove to be one successful 

reform solution to the civil jury decline 

problems facing litigants in those states. 

The Return of Fact-Based Pleading 

While many states have required factbased 

pleading for years, others are instituting 

similar requirements in order to 

increase the efficiency of the courts. Seen 

as a way to narrow the issues early in a 

case, which reduces the amount of discovery 

and its associated costs, some states are 

moving away from the issue- based pleading 

requirements of the federal courts. For 

example, the Colorado Civil Access Pilot 

Project requires parties to plead all material 

facts known to that party that support 

its claim or affirmative defense. 

In 2009, IAALS conducted a survey of 

attorneys and judges in Oregon, a state that 

preserved fact pleading in its state courts. 

When asked to compare the fact- pleading 

requirements in state court with the issuepleading 

requirements in federal court, 

responses were mixed as to whether fact 

pleading actually reduced the volume of 

discovery. When assessing the responses, 

39 percent of respondents agreed that fact 

pleading reduced the volume of discovery, 

while 55 percent disagreed. However, most 

attorneys stated that fact pleading increased 

their ability to prepare for trial and the efficiency 

of litigation. Interestingly, most attorneys 

disagreed that fact pleading generally 

favors defendants over plaintiffs. Of attorneys 

who represent only plaintiffs, 49 percent 

think fact pleading favors defendants. 

Conclusion 

DRI’s JPTF is monitoring these and other 

initiatives to ensure that the views and 

interests of DRI and its members are heard 

in the ongoing effort to preserve the jury 

trial. Other organizations have also been 

actively involved, including, but by no 

means limited to, the American College of 

Trial Lawyers, the American Board of Trial 

Advocates, the Conference of Chief Justices, 

and the American Bar Association. 

The goal of JPTF is to offer a defined set 

of proposals that individual members can 

take back to their states and use to build 

upon the successes of other members and 

jurisdictions. We welcome your views on 

these matters as we work to preserve this 

fundamental aspect of American justice, 

the civil jury trial.

DRI Expert Tracker offers the 

following proprietary benefits: 

Expert Tracker is 

accessible on the 

Members Only toolbar 

on dri.org 

Expert Witness Tracker 

Saved Searches 

Show 

10 

entries 

Search Name 

Date Added 

Search: 

Filbart Search 9/25/2012 2:09:24 PM 

Run this search Delete 

Dr. Filbart 9/25/2012 1:10:16 PM 


Fauntleroy - New York 9/14/2012 9:15:07 PM 


Alberts - CP 9/08/2012 3:58:03 PM 


Save, download 

and view all 

documents and 

searches within 

a customized 

user interface 

Wills - brakes 8/29/2012 11:22:42 PM 


Showing 1 to 5 of 9 entries 

FirstPrevious12NextLast 

Experts Tracked 

Show 

10 

Fred Filbart 

Dr. Cooper 

Dr. Addy 

entries 

Expert Name 

Jones - CP, fetal distress 

Tracking Note 

Date Added 

Track for George case 10/01/2012 9:38:02 AM Unsubscribe 

(Edit Note) 

Dr. Cooper field work 

(Edit Note) 

forensic anthropology 

(Edit Note) 

chorio tests, research 

(Edit Note) 

Sydni Schuylkill- mark-up possible for Anderson 

(Edit Note) 


9/29/2012 11:28:00 AM 

9/29/2012 2:14:11 PM 



Search: 

Unsubscribe 

Unsubscribe 

Unsubscribe 

Unsubscribe 

FirstPrevious12NextLast 

Track experts 

and receive 

e-mail 

notification 

when 

documents are 

Downloads/Annotations 

Show 

10 

Miscellaneous 

Deposition 

entries 

Expert 

Description 

Download Date 

Search: 

Contains 

Annotation 

Fred Filbart Track for George case 10/07/2012 No (Edit) 

10:40:12 AM 

David Gowley 

Danny v. Northern Interstates Hospital et al 

(trial transcript) 

10/06/2012 

1:04:06 PM 

Yes (Edit) 

Download 

Download 

Ability to create 

and append 

custom 

annotations to 

each document 

CV 

CV 

CV 

Welbert Johnson Curriculum Vitae 10/04/2012 

9:23:57 AM 

Yes (Edit) 

Anna Freud Curriculum Vitae 10/01/2012 Yes (Edit) 

6:14:32 PM 

E. Presley Curriculum Vitae 9/26/2012 Yes (Edit) 

12:44:42 PM 

Download 

Download 

Download 


FirstPrevious12NextLast


Medical Malpractice 

Defense 

By Robert C. Rouwenhorst 

The Role of 

the Nurse 

Paralegal 

Finding an intelligent, 

curious nurse willing 

to assist in representing 

clients with excellence 

may leave a defense 

attorney wondering 

how his or her practice 

could ever function 

as effectively without 

that nurse paralegal. 

■ Robert C. Rouwenhorst is the founder of Rouwenhorst & Rouwenhorst PC, with offices in West Des Moines and Council Bluffs, 

Iowa. He is a 20-year member of DRI. He practices as a trial and an appellate attorney with extensive experience defending 

medical malpractice cases involving physicians, nursing homes, hospitals, other professionals, and insurers in coverage litigation. 

Mr. Rouwenhorst lectures and writes on trial presentation strategies. 


Attorneys who defend medical malpractice cases on a regular 

basis should strongly consider employing a nurse 

paralegal to assist in all facets of case preparation and a 

trial. A nurse paralegal enhances the ability of an attorney 

to defend a medical professional in a costeffective 

manner without sacrificing quality 

of representation. 

Generally, nurses who work for attorneys 

fall into one of two categories: (1) an 

independent contractor legal nurse consultant, 

or (2) a nurse paralegal who is a law 

firm employee. An independent contractor 

legal nurse consultant usually works 

on specific projects selected by an employing 

attorney, but this nurse generally does 

not provide comprehensive work on a case. 

Legal nurse consultants are often hired by 

plaintiffs’ attorneys. One example of a project 

commonly assigned to a legal nurse 

consultant is to create a chronology of the 

medical records and to comment on the 

medical care that someone received. In 

contrast, a nurse paralegal employed by a 

law firm generally works on most aspects 

of a case from the beginning of the case 

through a trial. This article will focus on 

the role of a nurse paralegal employed by 

a medical malpractice defense law firm, 

drawing from our work with them in our 

law firm. 

Qualifications 

Hiring an appropriate nurse paralegal 

is vital because that employee will perform 

a critical number of functions on a 

defense team. When hiring a nurse paralegal, 

some attorneys place primary emphasis 

on lengthy experience in nursing, 

including experience in particular specialties 

such as orthopedics, cardiology, or 

critical care. Other attorneys place primary 

emphasis on educational background, including 

completion of formal training in 

an accredited nurse- consultant certification 

program. These are not unreasonable 

criteria, but they may not be the best criteria 

for choosing a first-rate nurse paralegal 

for a law firm specializing in medical malpractice 

defense. Our firm’s position ranks 

three criteria as more important than specialty 

nursing experience or formal training 

when selecting a nurse paralegal. These 

three important criteria are (1) intelligence; 

(2) communication skills; and (3) curiosity. 

Intelligence 

Nursing experience in a particular specialty 

or formal certification in nurse consulting 

does not guarantee the intelligence 

necessary to be an effective nurse paralegal. 

An intelligent nurse paralegal can learn 

and acquire new skills. Experience and certificates 

fade, but stupid is forever. 

A nurse paralegal is constantly confronted 

with new medical questions, new 

responsibilities, and requests for creative 

input into defense strategies for cases. A 

highly intelligent nurse paralegal tackles 

new medical problems with confidence. He 

or she uses contacts with physicians and 

medical literature to understand problems. 

An intelligent nurse paralegal takes on new 

responsibilities and learns quickly how to 

perform new tasks. An intelligent nurse 

paralegal can provide creative input during 

the brainstorming that occurs to develop 

themes of a case and defense strategies. 

Our firm uses a number of informal and 

formal strategies to produce a variety of creative 

solutions to problems in defending a 

case. The primary informal strategy that 

we use is to communicate frequently with 

our nurse paralegals when we defend cases, 

both orally and in writing. One goal of these 

communications must be absolute candor. 

A nurse paralegal’s talents are wasted if he 

or she is reluctant to tell the attorney that 

he or she is headed down a wrong path. Intelligent 

themselves, most defense attorneys 

do not suffer fools gladly. Intelligence 

in a nurse paralegal, therefore, is critical. 

Brainstorming helps generate numerous 

potential creative solutions to a problem. 

One method is to write the problem on 

large pieces of paper taped to a wall. Each 

participant then independently writes as 

many solutions as possible on a piece of 

paper without criticism or evaluation at 

this stage. The goal is to generate as many 

solutions as possible. Each member of the 

group then receives two small stickers to 

place next to the two ideas that he or she 

thinks best solve the problem. The responsible 

attorney may or may not participate 

in this phase, which can skew the results. It 

becomes readily apparent through this process 

which solutions seem most viable to 

the participants. If desired by the responsible 

attorney, the group can evaluate the 

ideas further using one or more of several 

techniques. See, e.g., Edward DeBono, Six 

Thinking Hats, (1985). An intelligent nurse 

paralegal will generate more potential solutions 

and better potential solutions during 

this process than a less intellectually 

gifted one. 

Communication Skills 

A nurse paralegal spends considerable time 

communicating with clients, insurance 

company representatives, experts, paralegals, 

witnesses, medical record custodians, 

medical librarians, office personnel, 

and most importantly, the supervising defense 

attorney. Communications occur both 

orally and in writing. Proficiency in both 

is vital for a nurse paralegal to perform his 

or her functions with excellence. If a nurse 

paralegal lacks proficiency in communication 

skills, the nurse paralegal can wreak 

havoc in the effective defense of a case. 

Clarity of communication minimizes misunderstandings 

and maximizes efficiency. 

Our firm, as do many, takes the position 

that one of the most important aspects of 

providing an excellent defense is to keep 

the client and the professional liability 

insurance carrier fully informed of the 

progress of a case. Our firm scans all documents 

of any significance and saves a copy 

of each to our in-house computer network 

as well as to an off-site server. This enables 

the nurse paralegal and others in the firm 

to access documents from any location. 

The nurse paralegal and the supervising 

attorneys in our firm largely communicate 

with others outside our firm by 

e-mail rather than by sending paper. Thus, 

it becomes a simple matter for the nurse 

paralegal to send information copies of all 

important documents by e-mail to a client, 

to the insurer, and to the supervising attorney. 

In this way, everyone receives continuous 

updates on the status of a case. The 

attorney can then focus on communicating 

with the client and the insurer regard- 



ing significant matters in a case knowing 

that they have received copies of documents 

that are under discussion. With the 

attorney and the nurse paralegal continuously 

sending each other copies of significant 

e-mails, the left hand knows what the 

right hand is doing. 

Communicating electronically is not 

enough, though. In our firm, the nurse 

An intelligentnurse 

paralegal can provide 

creative input during the 

brainstorming that occurs to 

develop themes of a case 

and defense strategies. 

paralegal’s office is located in close proximity 

to his or her primary supervising 

attorney. Thus, the day is frequently punctuated 

by face-to-face discussions about 

some aspect of a case. For a brief period, 

our firm’s nurse paralegal and her primary 

supervising attorney were located on different 

floors. This significantly impeded 

communication. Also, for a time, our firm’s 

nurse paralegal moved to another state and 

telecommuted. This impeded communication 

significantly. Easy and frequent faceto-face 

communication between a nurse 

paralegal and the supervising attorney is 

critical to producing an excellent defense. 

Empathy and understanding in communication 

encourages openness from all the 

persons with whom a nurse paralegal interacts. 

Ideally, a client, the experts, and others 

involved in the defense of a case in some 

way should feel just as comfortable talking 

to a nurse paralegal as they feel talking 

to a defense attorney. Furthermore, a 

nurse paralegal usually is more accessible 

than a defense attorney who has obligations 

in court, depositions, and other 

matters that can limit a defense attorney’s 

ability to immediately talk to a client or 

others. A nurse paralegal then serves as 

an immediate contact and often can provide 

information in a timely manner when 


someone requests it. A client, experts, and 

others take considerable satisfaction from 

this immediate availability. It eliminates 

telephone tag and conserves the time of a 

defense attorney so that he or she can deal 

with matters requiring his or her legal 

expertise. A nurse paralegal, because of 

his or her background, is uniquely suited to 

serve as an attorney’s “user- friendly interface” 

for medical professional clients. 

Curiosity 

A nurse paralegal who is curious educates 

him- or herself in areas of both medicine 

and the law. Such a nurse paralegal remains 

genuinely interested in the cases at hand. 

When we first hired her, one nurse paralegal 

who our firm employs, without being 

asked, read through the active case files to 

both learn about medical malpractice law 

and to become familiar with the facts and 

issues involved in the pending cases. That 

nurse paralegal remains a vital member of 

our firm’s defense team 19 years later. 

A nurse paralegal who is curious will 

search beyond the minimum requirement 

when his or her supervising attorney asks 

him or her to research something. Such 

a nurse paralegal is likely to provide the 

attorney with not just the answer to his or 

her question, but also information that is 

relevant to a case that the attorney did not 

ask him or her to research. Because of his 

or her understanding of medicine, a nurse 

paralegal is often in an excellent position to 

know the issues that a defense team should 

research, sometimes better than the supervising 

defense attorney. 

Mutual Education 

A nurse paralegal is trained in nursing and 

sees problems from a medical perspective. 

Although a nurse paralegal is not a physician, 

many have sufficient experience 

with physicians and training in medical 

terminology, algorithms, and heuristics 

to “think like physicians.” See, e.g., Stuart 

B. Mushlin & A. Harry L. Greene II, Decision 

Making in Medicine: An Algorithmic 

Approach (2010). An attorney is trained in 

the law and consequently sees problems 

from a legal perspective. 

Until an attorney has significant experience 

in the defense of medical malpractice 

cases, it is unlikely that he or she will 

find it easy to “think like” a physician. Until 

a nurse paralegal has significant experience 

in the defense of medical malpractice 

cases, it is unlikely that he or she will find 

it easy to “think like” an attorney. Ideally, 

by working together, the attorney gains 

growing understanding of medicine from 

the nurse paralegal and the nurse paralegal 

gains growing understanding of the law 

from the attorney. 

Case Management 

In our firm, after passing a conflict check, 

when a new case is assigned to our firm by 

an insurer, unless told otherwise, the supervising 

attorney and the assigned nurse 

paralegal both assume that the case will 

reach a trial and prepare the case accordingly. 

The nurse paralegal is normally involved 

in all aspects of case preparation. 

The nurse paralegal adds the descriptive information 

regarding the case to our “case 

status report,” which is stored in Microsoft 

Excel. This is an internal document that 

functions as a “to do list” regarding tasks 

that the supervising attorney and the nurse 

paralegal must undertake within the next 

few months. The nurse paralegal transfers 

the individual tasks to the respective electronic 

calendars of the supervising attorney 

and of the nurse paralegal with completion 

dates. The nurse paralegal is familiar with 

deadlines unique to medical malpractice 

cases so nobody misses important deadlines, 

and the supervising attorney and the 

nurse paralegal prepare the case in a proactive 

rather than a reactive manner. 


attorney meet on a regular basis to discuss 

the “case status report” and the necessary 

case preparation tasks. As a case progresses, 

the nurse paralegal updates the 

“case status report” to include such items 

as the initial meeting with the client; fact 

investigation required as a result of the 

meeting; possible case themes; defenses 

to the plaintiff’s petition or complaint; 

propounding discovery to the plaintiff; 

responses to discovery from the plaintiff; 

the detailed medical chronology; expert 

identification and retention; deposition 

scheduling; deposition preparation; record 

acquisition; discovery summarization; and 

written reports to the insurer. The supervising 

attorney and the nurse paralegal keep 

the client and the insurer fully informed as 

the case progresses.

The Client 

In our firm, the nurse paralegal contacts 

the client, usually a physician in these 

cases, and arranges a meeting with the 

physician, the assigned attorney, and the 

assigned nurse paralegal. It is crucial that 

the nurse paralegal attend the meeting for 

several reasons. Because the nurse paralegal 

is a nurse and physicians are accustomed 

to talking to nurses all the time, 

often a physician client is much more forthcoming 

with the facts, both good and bad, 

when talking to a nurse paralegal. A physician 

is less likely to believe that he or she 

can pull the wool over the eyes of a nurse 

paralegal given his or her training and 

experience compared to a defense attorney. 

Because of his or her training, a nurse 

paralegal is able to ask a physician pertinent 

questions that might not occur to 

a defense attorney. In our firm the nurse 

paralegal takes detailed notes during the 

meeting and later prepares a memo summarizing 

what a physician said for the 

supervising attorney’s use and the use of 

the professional liability insurance carrier. 

The attorney and the nurse paralegal 

discuss potential expert witnesses with 

the physician client to see if he or she has 

someone in mind or has any objection to 

the expert witnesses that the attorney is 

considering asking to review the case. The 

nurse paralegal reassures the physician 

so that the physician will feel comfortable 

communicating with him or her directly in 

the future. The nurse paralegal provides the 

physician with copies of two memos prepared 

by the attorney, one describing the 

litigation process and the other discussing 

how to deal with the cognitive distortions 

that a physician often suffers during litigation. 

See David D. Burns, Feeling Good: The 

New Mood Therapy (1980). 

Medical Records 

The nurse paralegal collects the relevant 

medical records from several sources: the 

physician client, the plaintiff, through written 

discovery, and third-party health-care 

providers, through the use of authorizations 

for release of information signed by 

the plaintiff or through subpoenas. Nursing 

judgment is involved in determining 

which medical records will likely be relevant 

to a case. In cases involving chronic 

conditions, it may be prudent to obtain 

decades of medical records. In cases involving 

short- lasting, acute conditions, it may 

be prudent initially to obtain three years 

of medical records. When the records are 

obtained, nursing judgment is involved 

in determining if additional records are 

required. The nurse paralegal generally 

makes these determinations in our firm. 

As the firm receives the medical records, 

the nurse paralegal prepares a detailed 

A DEEPER 

KNOWLEDGE 

OF YOUR 

PRACTICE 

As a lawyer, you understand your clients’ needs and you work diligently on their 

behalf. LawyerGuard has a deeper knowledge of the risks you face that can affect you 

both personally and professionally, and offers one of the strongest lawyers’ professional 

liability policy forms on the market today. This program evolved from over 20 

years of experience with defense attorneys, and is the only lawyers’ professional 

liability program sponsored by DRI. 

Our continued partnership with Catlin Insurance Company, Inc. makes this possible. 

Catlin is a leading global specialty insurer and reinsurer and also the sponsor of the 

2012 Catlin Seaview Survey, a scientific expedition set to carry out a pioneering 

study of Australia’s Great Barrier Reef. The project will document the health and 

composition of this vital ecosystem and address important questions regarding 

changes associated with rapidly warming oceans. Find out more at www.catlin.com. 

Have your agent contact Stephen van Wert at LawyerGuard via phone 813-712-7032, 

email stephen.vanwert@willis.com or visit www.lawyerguard.com 

We Know Your Business. 



medical chronology in a Microsoft Excel 

table. The medical chronology that our 

firm uses is prepared in landscape format 

and has the following columns: date, time, 

author, record type, summary, source of 

record, page number, and comments. The 

comments are those of the nurse paralegal 

and contain some of the most helpful 

information, for instance, identifying 

A physicianis less likely 

to believe that he or she 

can pull the wool over the 

eyes of a nurse paralegal 

given his or her training 

and experience compared 

to a defense attorney. 

additional information the attorney and 

nurse paralegal should obtain. A copy of 

this medical chronology is provided to the 

client and the insurer. Microsoft Excel has 

many advantages: the nurse paralegal can 

add additional records easily to the medical 

chronology and use the sorting functions 

to make reviewing it easier, for example, 

by grouping every document authored by 

a client in chronological order. 

After completing the detailed medical 

chronology, the nurse paralegal prepares 

an overview memo summarizing 

the highlights of the most relevant medical 

information in a case. This memo generally 

concludes with a “to do list” that is 

transferred to the “case status report” and 

the task list in the calendars of the nurse 

paralegal or of the supervising attorney, 

depending on to whom the task would 

most appropriately belong. 

Experts 

The nurse paralegal maintains our firm’s 

database of experts used in the past or with 

whom our attorneys have become familiar. 

Sometimes the nurse paralegal searches for 

experts who have published on a particular 

topic. After the nurse paralegal and the 


supervising attorney discuss who should 

be asked to review the case, the nurse paralegal 

contacts the expert. This is one area 

where the nurse paralegal’s communication 

skills and professional background 

come into play. The nurse paralegal is generally 

able to convince an expert’s assistant 

to at least make an appointment so that the 

nurse paralegal can have a telephone conference 

with the potential expert. 

The nurse paralegal discusses the case 

with the expert and determines if the 

expert is willing to review it. If so, the nurse 

paralegal obtains some basic information, 

requests a copy of the expert’s curriculum 

vitae, and determines the number of times 

that the expert has testified by a deposition 

or during a trial, as well as how many times 

the expert has testified for a plaintiff or for 

a defendant. The nurse paralegal also determines 

the expert’s hourly rate for reviewing 

documents, participating in telephone 

conferences, and offering depositions and 

trial testimony. The nurse paralegal determines 

if the expert is willing to testify during 

a trial or if the expert will only agree to 

testify by a deposition. 

The nurse paralegal then provides all 

this information, as well as a copy of the 

expert’s curriculum vitae, to the professional 

liability carrier and obtains approval 

of the carrier before sending anything to 

the expert to review. Once a carrier has 

approved an expert, the nurse paralegal 

then sends two letters to the expert over the 

attorney’s signature. The first letter confirms 

the terms of the engagement to prevent 

a dispute later about what an expert 

charges. The second letter accompanies a 

disk containing copies of the petition and 

the medical records in PDF format. The second 

letter confirms that the expert agrees 

to comply with HIPAA or to return the disk 

without reviewing the records. The nurse 

paralegal then will schedule a telephone 

conference during which the nurse paralegal 

and the supervising defense attorney 

will learn the expert’s initial opinion. After 

the telephone conference, the nurse paralegal 

prepares a memo summarizing the telephone 

conference and provides copies to 

the client and to the insurer. 

As the firm receives additional medical 

records, depositions, and other documents, 

the nurse paralegal provides copies to the 

expert witnesses to review. At appropriate 

times, the nurse paralegal will schedule a 

telephone conference with each expert so 

that the nurse paralegal and the supervising 

attorney can determine if and how the 

new information has affected an expert’s 

opinion. Again, the nurse paralegal prepares 

a memo summarizing the telephone 

conference and shares it with the client and 

the insurer. 

Medical Literature Research 

Generally, experts will identify the most 

relevant medical literature on a particular 

topic for a defense attorney. The nurse 

paralegal obtains copies of that literature 

and supplies it to the attorney. If for some 

reason the expert is not helpful in identifying 

pertinent medical literature, then the 

nurse paralegal has responsibility for identifying 

it. Medical information sites on the 

Internet, state medical libraries, medical 

school libraries, and hospital libraries are 

useful sources of information. Most libraries 

employ staff specifically trained to conduct 

medical literature searches no matter 

how arcane the topic. An intelligent nurse 

paralegal cultivates a good relationship 

with those staff members. 

After obtaining the medical literature, 

the nurse paralegal then reviews it and 

either highlights the most important information 

or creates a memo summarizing 

the most important information. Many 

medical textbooks are three or more years 

out of date before they are published. However, 

some medical textbooks are extremely 

helpful to an attorney needing an overview 

of a particular subject, even if the textbook 

is somewhat dated. 

The Internet and paper publications can 

be rich sources of medical illustrations. 

As required, the nurse paralegal contacts 

a copyright holder and negotiates the cost 

of obtaining a limited copyright license for 

each illustration used during a trial. 

Preparing a Client for a Deposition 

A client cannot win his or her case during 

his or her deposition; however, he or she 

can lose it. Therefore, preparing a client 

for a deposition is imperative. The nurse 

paralegal provides an extensive memorandum 

prepared by the supervising attorney 

to the physician client about how to offer 

good deposition testimony. Also, the nurse 

paralegal provides the physician client with

a DVD to watch about offering deposition 

testimony. 


attorney meet with the client to practice 

offering a deposition. The supervising 

attorney asks the client questions that an 

opposing attorney likely will ask during 

the deposition. The nurse paralegal takes 

a digital video during the practice session. 

They stop recording approximately every 

10 minutes, and the physician, the attorney, 

and the nurse paralegal watch the 

video on a computer monitor. One picture 

is worth 1,000 words. Showing a client a 

video effectively conveys to a client what 

is wrong with the testimony and how he 

or she can improve it. In our experience, 

the nurse paralegals who have worked for 

our firm have made particularly effective 

observations and suggestions in an empathetic 

manner. 

Preparation for Depositions 

of Opposing Experts 

While our firm’s attorneys have several 

important goals when deposing an opposing 

expert, almost without exception, the 

primary goal is to obtain “sound bites” to 

use against the expert during a trial. For 

example, an attorney might ask, “Have 

you ever failed a board certification examination” 

If the expert answers “yes,” the 

attorney has a marvelous sound bite to use 

during a trial. Brief sound bites usually 

discredit an opposing expert more effectively 

during a trial than lengthy deposition 

excerpts that jurors might find hard 

to follow. Jurors understand and remember 

a sound bite. See, e.g., Chip Heath & 

Dan Heath, Made to Stick: Why Some Ideas 

Survive and Others Die (2007). 

To draw out sound bites, first the nurse 

paralegal thoroughly researches the background 

of each opposing expert. He or she 

verifies that the items on the expert’s curriculum 

vitae are accurate. For example, 

an opposing expert in a case that our firm 

recently handled indicated on his curriculum 

vitae that he was on the medical staffs 

of five hospitals. The nurse paralegal contacted 

the hospitals and found he was on 

the medical staffs of only one of the five. 

The nurse paralegal then obtained letters 

from the other four hospitals confirming 

the expert was not a staff member. Using 

social media and the Internet a nurse paralegal 

may find that an expert advertises his 

or her services as a witness online or that 

the expert is listed with a company that 

supplies experts to attorneys. Either way, 

it appears that the expert offers his or her 

opinions for sale. 

The nurse paralegal also reviews the 

previous deposition testimony of experts 

by contacting IDEX or DRI and obtaining 

copies of transcripts of the expert’s previous 

testimony in other cases. The nurse paralegal 

then highlights the sound bites in the 

transcripts so that the supervising attorney 

can ask the expert the same questions 

during a deposition and hopefully then will 

elicit the same sound bites to use during the 

upcoming trial in our case. Previous depositions 

generally are filled with fodder for creating 

sound bites to use later during a trial 

to impeach an expert, and a skilled nurse 

paralegal will ferret out those sound bites. 

The nurse paralegal also prepares 

memos summarizing the medical experts’ 

deposition testimony, and in the case of 

opposing experts, suggest areas potentially 

open to attack during a trial. This is 

not to say that an attorney should rely on a 

nurse paralegal to prepare direct examination 

and cross- examination questions for 

experts. However, a nurse paralegal generally 

suggests insightful questions, particularly 

from a medical standpoint. 

Information Management 

The nurse paralegal in our firm takes on 

the responsibility for finding information 

when the supervising attorney needs it. The 

nurse paralegal takes a very active role in 

monitoring our firm’s electronic and paper 

filing systems. Virtually without exception, 

the nurse paralegal can access and provide 

the required information. Our system has 

several features. All incoming documents 

are scanned into the on-site computer system 

by a file clerk using Adobe Acrobat, 

and simultaneously they are saved to the 

remote server. To the extent that a document 

is compatible with optical character 

recognition, the system recognizes the text 

as well. We save all the documents that we 

generate both to the on-site computer system 

and to the remote server. Saving documents 

to the remote server enables the 

nurse paralegal and the supervising attorney 

to access all the documents from any 

location with Internet access. 

All the electronic documents can be 

searched by the filename or for terms in the 

text of a document. However, with paper 

documents, the nurse paralegal writes on 

each document specifically where it is to 

be filed using a long- standing system. Designating 

the filing destination guides a file 

clerk and eliminates guesswork from the 

job. Firms can waste a great deal of time 

The nurse paralegal 

has unique insight into 

how to use medical 

illustrations, timelines, 

and other demonstrative 

evidence effectively 

to introduce complex 

medical issues to a jury. 

searching for particular paper and or electronic 

documents if file clerks don’t receive 

filing location guidance. 

An effective information management 

system should allow an attorney to organize 

information in one or more of five 

ways: location, alphanumeric, chronological, 

category and hierarchy. The paper filing 

system used by the nurse paralegal 

organizes paper categorically and alphanumerically. 

It involves seven categories of 

numbered and color-coded files for (1) correspondence, 

(2) pleadings, (2.1) expert 

designations, (3) discovery subfiles, (4) topical 

subfiles, (5) expert subfiles, (6) fact 

witness subfiles, and (7) medical record 

subfiles. Each subfile is filed alphabetically 

within its numerical category. The nurse 

paralegal has a master index of all the subfiles 

to consult. Because a file bears the 

name of the case, the numerical category 

of the subfile, and the color-coded label 

assigned to each numerical category, it usually 

takes less than a minute for the nurse 

paralegal to locate an errant, misfiled subfile. 

Paper documents are destroyed at the 

Nurse Paralegal, continued on page 80 



Fitting a Round Peg 

into a Square Hole 

By Frederick H. Fern 

and Kelly E. Jones 

It is time for the FDA 

to rethink policy, as the 

prohibition on off-label 

marketing and the recent 

Guidance on responding 

to unsolicited requests 

for information do little 

to advance the agency’s 

mission to ensure that 

all drugs and devices 

are safe and effective. 


FDA Off-Label 

Promotion Rules 

in the World of 

Social Media 

The Food and Drug Administration (FDA) released new 

draft guidance on December 23, 2011, entitled, “Responding 

to Unsolicited Requests for Off- Label Information 

about Prescription Drugs and Medical Devices.” The guid- 

■ Frederick H. Fern, a registered pharmacist, is a member of Harris Beach PLLC in New York City and the 

leader of its Medical & Life Sciences Practice Group and a member of the DRI Drug and Medical Device 

Committee. Kelly E. Jones is a senior associate with Harris Beach PLLC and focuses her practice in New 

York and New Jersey on litigation and consulting involving FDA- regulated products. Ms. Jones serves on the 

steering committees for the DRI Drug and Medical Device and Young Lawyers Committees. A special thank 

you to Andre Major, a third-year law student at Brooklyn Law School, for his assistance with this article.

ance advises how firms such as manufacturers 

and distributors of pharmaceuticals 

and medical devices should respond to requests 

for information about unapproved 

or “offlabel” uses for FDA- approved drugs 

and medical devices. The impetus for the 

guidance has been the continuing expansion 

and prevalence of the Internet and 

social media, and the industry’s resulting 

uncertainty regarding how to respond to 

information posted publicly and questions 

about offlabel uses in light of the strict FDA 

ban on marketing for offlabel indications. 

Though the FDA has not yet finalized the 

guidance, in its current form it will do little 

to resolve uncertainties. First, the guidance 

doesn’t clearly distinguish between solicited 

and unsolicited requests for offlabel information 

and will chill the dissemination of 

valuable information about offlabel uses. 

Second, the guidance unduly limits the permitted 

exchanges of valuable medical information 

that may adversely affect the public 

health. Finally, the guidance does not take 

into consideration the burgeoning case law, 

particularly the recent Supreme Court decision 

Sorrell v. IMS Health, which strongly 

suggests that the FDA ban on truthful marketing 

of offlabel uses is an unconstitutional 

restriction of commercial speech. 

Background 

The Food, Drug and Cosmetic Act (FDCA) 

prohibits manufacturers from marketing 

or promoting offlabel drug uses. The FDA 

had interpreted a combination of provisions 

as effectively having made it illegal for 

manufacturers to disseminate information 

regarding indications for use that the FDA 

has not approved. The FDCA makes it illegal 

for a manufacturer to introduce a drug 

into interstate commerce unless the product 

has undergone clinical trials demonstrating 

safety and efficacy for its intended 

uses. See 21 U.S.C. §355(a), (b) (2006). Furthermore, 

the FDA must approve the labeling 

of a new product for all of its intended 

uses; namely, the product’s directions for 

use, its indications, and its side effects. 21 

U.S.C. §352(f) (2006). Moreover, the FDA 

interprets a manufacturer’s intended use 

by examining “labeling claims, advertising 

matter, or oral or written statements 

by such persons or their representatives.” 

21 C.F.R. §201 (2012). 

Accordingly, if a manufacturer markets 

an approved drug for an indication not yet 

approved by the FDA, it “becomes an unapproved 

new drug with respect to that use.” 

65 Fed. Reg. 14,286 (2000). An unapproved 

new drug by definition would have insufficient 

labeling and inadequate use directions. 

See 21 U.S.C. §352(f) (2006); Wash. 

Legal Found. v. Friedman, 13 F. Supp. 2d 

51, 54–55 (D.D.C. 1998). Consequently, a 

manufacturer must seek and obtain FDA 

approval for any new indication; otherwise 

any marketing of that offlabel use is 

considered misbranding and violates the 

FDCA labeling mandates, regardless of 

the truthfulness of the information. See 21 

U.S.C. §352 (2006); John E. Osborn, Can I 

Tell you the Truth A Comparative Perspective 

on Regulating Off- Label Scientific and 

Medical Information, Yale J. Health Pol’y & 

Ethics 299, 329 (2010). Violating the FDCA 

misbranding provisions also potentially 

subject violators to treble damages and qui 

tam actions under the False Claims Act 

(FCA) for “knowingly mak[ing], us[ing], or 

caus[ing] to be made or used, a false record 

or statement material to a false or fraudulent 

claim.” 31 U.S.C. §3729(a)(1)(B) (2006); 

Osborn, supra, at 310–11. Furthermore, 

any person convicted of illegally marketing 

a drug is guilty of a misdemeanor. See 

21 U.S.C. §331 (2006). 



While the FDCA serves nearly to ban 

offlabel marketing absolutely, a physician 

has limitless ability to prescribe a medication 

for an offlabel use. Physicians have the 

absolute discretion to prescribe a medication 

for any purpose that they deem medically 

appropriate, regardless of whether 

the FDA has approved the drug for that 

indication. Incongruity aside, this policy 

As the Internet and social 

media have expanded 

and facilitated the spread 

of information, the FDA 

policy on offlabel use 

marketing has become 

increasingly unrealistic. 

acknowledges that completely banning 

offlabel drug use is untenable because in 

many instances—particularly in pediatrics 

and oncology—such offlabel uses represent 

novel and cutting- edge treatment for 

certain medical conditions. See Osborn, 

supra, at 303–04. It is widely accepted that 

the time- consuming and costly nature of 

the FDA approval process means that it is 

often economically unfeasible for a manufacturer 

to test all potential offlabel usages 

for a drug. See Anna B. Laakmann, Collapsing 

the Distinction Between Experimentation 

and Treatment in the Regulation 

of New Drugs, 62 Ala. L. Rev. 305, 317– 

18 (2011). Therefore, an outright ban on 

offlabel usage would invade the province 

of the practice of medicine and in many 

instances prevent patients from receiving 

the best or only drug available for treating 

a medical condition. 

Ostensibly, the FDA offlabel use marketing 

ban seeks to prevent manufacturers 

from promoting offlabel uses that have 

not endured the rigorous FDA screening 

process. Belying this justification, however, 

the FDA has failed to distinguish 

between “truthful” and “misleading” offlabel 

use marketing or to take into account 


the unfettered discretion that physicians 

have to prescribe medication for offlabel 

uses. Furthermore, as the Internet and 

social media have expanded and facilitated 

the spread of information, the FDA policy 

on offlabel use marketing has become 

increasingly unrealistic. It ignores that 

the public has wide access to information 

about offlabel uses and widely seeks 

this information. See Susannah Fox, The 

Social Life of Health Information, Pew 

Internet & American Life Project 2 (May, 

12 2011), http://pewinternet.org/~/media//files/ 

reports/2011/pip_social_life_of_health_info. 

pdf. Accordingly, this policy is unsustainable, 

as the recently released FDA guidance 

highlights in advising firms how to 

respond to unsolicited requests for information 

about offlabel uses. 

The FDA Draft Guidance 

On December 23, 2011, the FDA released a 

draft guidance document directed to the 

industry entitled, “Responding to Unsolicited 

Requests for Off- Label Information 

about Prescription Drugs and Medical 

Devices.” The FDA sought through the 

draft guidance “to describe the [FDA’s] 

current thinking about how manufacturers 

and distributors… can respond to 

unsolicited requests for information about 

unapproved or uncleared indications or 

conditions of use.” U.S. Food and Drug 

Admin., Guidance for Industry Responding 

to Unsolicited Requests for Off- Label 

Information about Prescription Drugs and 

Medical Devices, Draft Guidance, 1 (Dec. 

2011), http://www.fda.gov/downloads/drugs/ guid 

ancecomplianceregulatoryinformation/guidances/ 

ucm285145.pdf. Specifically, the draft guidance 

explains how the FDA differentiates 

a solicited request for information from an 

unsolicited request and the proper procedures 

for responding to public and private 

unsolicited requests about offlabel uses. 

Solicited requests are those “requests for 

offlabel information that are prompted in 

any way by a manufacturer or its representatives.” 

U.S. Food and Drug Admin., 

Unsolicited Requests, supra, at 5. A firm 

cannot solicit requests for information for 

offlabel use, and the FDA may consider 

this evidence that the firm sought to market 

a medication for a new intended use 

in violation of the FDCA. See id. The draft 

guidance provides numerous examples of 

solicited requests. For instance, the FDA 

would view a manufacturer’s sales representative 

mentioning an offlabel use 

and inviting a health-care professional to 

request more information about the use 

as a solicited request. On the other hand, 

an unsolicited request is one “initiated 

by persons or entities that are completely 

independent of the relevant firm.” Id. at 4. 

Stated succinctly, a request for information 

is unsolicited when it was not “prompted in 

any way by [the] manufacturer or its representatives.” 

Id. 

The draft guidance further subdivides 

unsolicited requests into public and nonpublic 

requests and defines each. According 

to the draft guidance, “[a] nonpublic 

unsolicited request is an unsolicited request 

that is directed privately to a firm using a 

one-on-one communication approach.” Id. 

(mentioning an e-mail from an individual 

directed to the medical information staff 

of a manufacturer about an offlabel use as 

an example of a private communication). 

A public unsolicited request is one “made 

in a public forum, whether directed to a 

firm specifically or to a forum at large.” Id. 

(mentioning posting a question about an 

offlabel use of a specific product on a firmcontrolled 

website or third-party forum 

accessible to a broad audience as an example 

of a public forum). The draft guidance 

then delineates the proper way to respond 

to each type of request. 

The draft guidance lists the information 

that firms should include in all responses 

to nonpublic unsolicited requests about 

offlabel uses. The FDA directs firms to 

answer unsolicited requests with “truthful, 

balanced, nonmisleading, and 

non- promotional scientific or medical 

information that is responsive to the specific 

request.” Id. at 6–7. Moreover, when 

a firm responds to a nonpublic request, 

the firm should distribute the information 

only to the person making the request “as 

a private, one-on-one communication,” 

and the information “should be tailored to 

answer only the specific question(s) asked.” 

Id. at 7 (indicating that if a firm receives a 

broad request the firm should narrow the 

response as much as possible). Furthermore, 

information in a response should be 

“truthful” and “scientific in nature,” independent 

medical or scientific personnel 

should generate it, and publications that

are contrary to or call into question the 

use at issue should accompany it. Id. at 8 

(suggesting that to the greatest extent possible 

firms should rely on “published peerreviewed 

articles, medical texts, or data 

derived from independent sources”). As 

mentioned, a firm response to a nonpublic 

request should originate with medical 

or scientific personnel as opposed to sales 

or marketing personnel, and the following 

information should accompany it: a copy 

of the approved FDA labeling, a statement 

that the FDA has not approved the drug for 

the offlabel use, a statement detailing the 

FDA- approved uses of the drug, a statement 

listing all important safety information, 

and a complete list of all references for the 

information disseminated in the response. 

Id. at 9 (also imposing a responsibility on 

the manufacturer to maintain records, 

particularly of the nature of the request 

for information, the information provided 

responding to the request, and follow- up 

questions received from the requestor). 

The draft guidance makes a separate 

set of recommendations for responding to 

an unsolicited public request. Specifically, 

if the request for offlabel information is 

made in a public forum, then a responding 

firm cannot respond in the same forum, 

which would then make the information 

available to the public and which the FDA 

would consider evidence of an intended offlabel 

use. Id. at 10. (citing dual concerns 

that publicly posted information “is likely 

to be available to a broad audience for an 

indefinite period of time” and about the 

“enduring nature of detailed public online 

responses to offlabel questions because 

specific drug or device information may 

become outdated). Furthermore, the draft 

guidance directs that firms should not 

respond to any public inquiry unless the 

request specifically refers to a product by 

name, and if a firm decides to respond 

publicly to such a request, the response 

should be limited to providing the manufacturer’s 

contact information for the medical 

or science department and “should not 

include any offlabel information.” Id. at 11 

(emphasis in original). Finally, anytime a 

representative of a manufacturer responds 

to an unsolicited request, the representative 

should disclose the involvement with 

the manufacturer and should refrain from 

adopting promotional tones. Id. at 12. 

The Shortcomings of the 

FDA Draft Guidance 

Unless the FDA makes major modifications 

before finalization, the guidance as 

it stands will potentially increase uncertainty 

for drug manufacturers. Right now 

it doesn’t achieve its stated purpose: to 

“clarif[y] [the] FDA’s policies on unsolicited 

requests for offlabel information, 

including those that firms may encounter 

through emerging electronic media.” 

U.S. Food and Drug Admin., Unsolicited 

Requests, supra, at 1. 

For example, two means by which the 

draft guidance differentiates a solicited 

request from an unsolicited request are 

troublesome. This is especially true given 

that firms cannot respond to unsolicited 

requests, and making a mistake distinguishing 

between a solicited and an unsolicited 

request could elicit a violation. The 

draft guidance twice emphasizes that the 

FDA considers a request solicited if it is 

“prompted in any way by a manufacturer or 

its representatives.” Id. at 4, 5. This distinction 

could potentially subject manufacturers 

to liability for a variety of innocent and 

widespread industry practices. For example, 

according to the broad language in the 

draft guidance, when a sales representative 

asks a group of physicians if the physicians 

have any questions and one or more 

of those physicians respond with questions 

about offlabel use, the FDA would consider 

this a solicited request. Technically, the 

sales representative’s question “prompted” 

the physicians’ inquiries. Moreover, if the 

FDA categorizes these inquiries as solicited, 

then the FDA might consider any 

response at all—even to convey truthful 

information or to offer the manufacturer’s 

contact information—evidence of promoting 

an offlabel use. See id. at 4–5. 

According to the draft guidance, the FDA 

will consider a request unsolicited only if it 

is “initiated by persons or entities that are 

completely independent of the [drug manufacturer].” 

Id. at 4. The FDA in the draft 

guidance does not clearly define “completely 

independent.” While the draft guidance 

lists some of the medical professionals 

that the FDA may consider independent, 

it does not acknowledge that exceedingly 

commonly a drug manufacturer will have 

interactions with physicians or health-care 

organizations or recommend how a drug 

Anytimea representative 

of a manufacturer responds 

to an unsolicited request, 

the representative should 

disclose the involvement 

with the manufacturer 

and should refrain from 

adopting promotional tones. 

manufacturer should interact with them. 

Id. For example, would the FDA view a physician 

or a health-care organization as relinquishing 

independence when they form 

purchasing or consulting agreements with 

a manufacturer Moreover, if that physician 

or organization suddenly becomes affiliated 

with a drug manufacturer, would 

any question they asked about offlabel usage 

become solicited, subjecting the manufacturer 

to liability for responding 

These ambiguities regarding the distinction 

between solicited and unsolicited 

requests can have a chilling effect 

on the dissemination of valuable medical 

information. If a drug manufacturer 

is found to have promoted an offlabel use 

illegally, it would potentially incur billions 

of dollars in fines. For example, in 

July 2012, GlaxoSmithKline agreed to pay 

$3 billion to settle claims it illegally promoted 

offlabel uses for Paxil and Wellbutrin. 

Jesse J. Holland, GlaxoSmithKline 

to Pay $3 Billion for Health Fraud, S.F. 

Chron., July 2, 2012, http://www.sfgate.com/ 

news/article/ GlaxoSmithKline-to-pay-3-billion-forhealth-fraud-3678945.php 

(last visited Sept. 10, 

2012). Because drug manufacturers potentially 

face massive penalties for offlabel 

drug-use marketing, they will understandably 

err on the side of caution with ambiguous 

guidance activities which migh expose 

firms to those penalties. Inevitably healthcare 

professionals will not have access to 

vital medical information that they should 

have access to, and their patients will not 



receive the most innovative treatments 

available for their medical conditions. 

In addition to having a chilling effect, if 

adopted as it stands the FDA guidance also 

may unduly burden permissible exchanges 

of medical information. For example, irrespective 

of the forum, a firm can only 

respond to a question about offlabel information 

directly “to the individual making 

Unless the FDAmakes 

major modifications before 

finalization, the guidance 

as it stands will potentially 

increase uncertainty for 

drug manufacturers. 

the request… as a private, one-on-one communication.” 

U.S. Food and Drug Admin., 

Unsolicited Requests, supra, at 7. This example 

in the draft guidance illustrates the 

misguided nature of the policy regarding 

public requests for information: the FDA 

will classify a request as a public request 

when someone asks a manufacturer’s representative 

a question about an offlabel use 

during a live presentation to multiple people. 

According to the draft guidance, any 

response must be “limited to providing the 

firm’s contact information and should not 

include any offlabel information.” Id. at 11 

(emphasis in original). Notably, this same 

scenario applies to most requests submitted 

through social media. If an individual posts 

a question about an offlabel use in a public 

Internet forum, a response can only consist 

of the firm’s contact information. This policy 

is counterproductive. By not responding 

to a direct question with a direct answer it 

appears that a firm has something to hide, 

and the inquiring health care professional 

cannot receive a prompt answer to a legitimate 

medical question. 


Off-Label Marketing and 

the First Amendment 

Clearly some of the policies proposed by the 

FDA in the draft guidance regarding unsolicited 

requests for offlabel use information 

do not advance public health, but the 

general FDA policy on offlabel marketing 

also may violate the First Amendment. Historically, 

commercial speech was not considered 

protected speech, but over the past 

40 years commercial speech increasingly 

has garnered First Amendment protection. 

This trend began in 1976 with the Supreme 

Court decision that a Virginia law prohibiting 

advertising prescription drug prices 

violated the First Amendment. Va. State 

Bd. of Pharmacy v. Va. Citizens Consumer 

Council, Inc., 425 U.S. 748 (1976). Four 

years later, in Central Hudson Gas & Electric 

Corp. v. Pub. Serv. Comm’n, the Court 

established a four-prong test for determining 

whether particular commercial 

speech deserves First Amendment protection 

from government regulation. 447 U.S. 

557 (1980). 

The test espoused in Central Hudson— 

still the controlling standard—first evaluates 

whether the speech promotes illegal 

activity or misleads. If so, the speech would 

not warrant protection. If the speech promotes 

legal activity and is truthful, then the 

second question a court asks is whether the 

restriction advances a substantial government 

interest. If a court determines that the 

restriction advances a substantial government 

interest, then a court would next ask 

whether “the regulation directly advances 

the government interest asserted.” Finally, 

the last prong asks “whether [the regulation] 

is not more extensive than is necessary 

to serve that interest.” Id. at 566. The 

government bears the burden of persuasion 

for the final three prongs, and if the 

government does not meet the burden for 

all three, a court generally will find the regulation 

unconstitutional. Coleen Klasmeir 

& Martin H. Redish, Off- Label Prescription 

Advertising, the FDA and the First Amendment: 

A Study in the Values of Commercial 

Speech Protection, 37 Am. J. L. and Med. 

315, 338 (2011). 

Under the Central Hudson framework, 

commercial speech has received expanding 

First Amendment protection. See, e.g., 

Sorrell v. IMS Health Inc., 131 S. Ct. 2653 

(2011); Thompson v. W. States Med. Ctr., 

535 U.S. 357 (2002); Lorillard Tobacco Co. 

v. Reilly, 533 U.S. 525 (2001). The case law 

under the Central Hudson framework may 

support the proposition that the federal 

ban on offlabel drug-use marketing may 

be unconstitutional. 

Under the first prong of the Central 

Hudson test, the commercial speech must 

promote lawful activity and be truthful 

to warrant First Amendment protection. 

Courts have held that offlabel marketing 

satisfies this prong as long as the information 

disseminated is not inherently misleading 

because the underlying activity 

being promoted—offlabel use of an FDAapproved 

drug—is lawful. United States v. 

Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y. 

2008) (citing Wash. Legal Found. v. Friedman, 

13 F. Supp. 2d 51, 66–67 (D.D.C. 1998) 

(defining inherently misleading as “more 

likely to deceive the public than inform it”); 

United States v. Caputo, 288 F. Supp. 2d 912, 

920–21 (N.D. Ill. 2003). Advertising is not 

inherently misleading because it promotes 

a particular point of view. The Supreme 

Court has stated that it is unlawful to ban 

truthful advertising that does not mislead 

simply because it has an effective sales 

pitch. See Sorrell, 131 S. Ct. at 2671; Liquormart, 

Inc., 517 U.S. at 503 (“Bans on truthful, 

nonmisleading commercial speech… 

usually rest on the offensive assumption 

that the public will respond irrationally to 

the truth”). See also U.S. Food and Drug 

Admin., Unsolicited Requests, supra, at 

10 (acknowledging that manufacturers 

are capable of responding to requests for 

offlabel information in a “truthful, nonmisleading, 

and accurate manner”). 

Once a manufacturer demonstrates that 

the disseminated information is truthful, 

as mentioned the burden shifts to the government 

to justify the commercial speech 

regulation. The first part of this burden, the 

second prong discussed in Central Hudson, 

requires the government to show that the 

regulation restricting commercial speech 

advances a substantial government interest. 

This is a relatively easy burden for the 

agency to satisfy, and courts have held 

that the FDA position that the ban encourages 

manufacturers to participate fully in 

the FDA regulatory process is sufficient. 

Thompson, 535 U.S. at 369–70 (holding that 

the government has a substantial government 

interest preserving the FDA new drug 

approval process). But cf. Friedman, 13 F. 

Supp. 2d at 69–71 (ensuring that physicians 

receive accurate and unbiased information 

does not qualify as a substantial gov-

ernment interest); Klasmeir, supra, at 346. 

Consequently, a successful First Amendment 

challenge to the FDA ban on offlabel 

drug-use marketing will likely have to 

demonstrate that the FDA has failed to satisfy 

the third or fourth prongs of the Central 

Hudson test or both prongs. 

The third prong requires the FDA to 

show that the ban on offlabel marketing 

directly advances the government interest 

asserted. Whether the FDA can satisfy this 

burden regarding offlabel drug-use marketing 

is questionable even though current 

case law holds that an offlabel marketing 

ban does directly advance a substantial 

government interest in preserving the 

integrity of the FDA approval process. See 

Thompson, 535 U.S. at 371(finding that prohibiting 

advertising for products that have 

not undergone FDA screening may encourage 

manufacturers to submit their products 

to the testing process); Friedman, 13 

F. Supp. 2d at 72 (determining that “one of 

the few mechanisms available to the FDA to 

compel manufacturers behavior is to constrain 

their marketing options; i.e., control 

the labeling, advertising and marketing”). 

Accord Caronia, 576 F. Supp. 2d at 401. 

However, as the third prong analyzes 

the asserted government interest, if the 

asserted interest encompasses the stated 

interest of protecting the public health, then 

the current FDA policy does not directly 

advance that interest. See U.S. Food and 

Drug Admin., Unsolicited Requests, supra, 

at 3. The FDA draft guidance acknowledges 

that “offlabel uses or treatment regimens 

may be important therapeutic options and 

may even constitute a medically recognized 

standard of care” and that manufacturers 

often have the most complete information 

about a drug’s offlabel use. See id. at 

2. Consequently, a persuasive argument 

exists that current FDA policy has a detrimental 

effect on the public health because 

firms cannot inform physicians about therapeutic 

offlabel uses. Due to the FDA policies 

limiting dissemination of information, 

patients may not receive the most innovative 

therapies for their conditions. See Klasmeir, 

supra, at 346. Accordingly, depending 

on the level of generality used to characterize 

its justification, the FDA draft guidance 

policies arguably does not satisfy the 

Central Hudson third prong because the 

policies prevent the dissemination of valuable 

information, which negatively affects 

the availability of helpful medical treatments. 

That the proposed policies articulated 

in the FDA draft guidance includes 

forbidding firms from publicly correcting 

untrue or misleading information about 

offlabel drug uses further undermines that 

FDA-stated purpose to make helpful medical 

treatments available. See U.S. Food and 

Drug Admin., Unsolicited Requests, supra, 

at 10–12. 

The government must also satisfy the 

fourth prong of the Central Hudson test, 

whether a regulation is more restrictive 

than necessary to promote a substantial 

government interest. The government 

might have problems with this prong 

because current case law suggests that the 

prohibition on offlabel drug-use marketing 

may not satisfy that burden. In Wash. Legal 

Found. v. Friedman, the court held that 

prohibiting the distribution of independent 

textbook excerpts and article reprints from 

medical and scientific journals concerning 

offlabel drug uses was unconstitutional 

because the regulation was more extensive 

than was necessary to advance the substantial 

government interest in encouraging 

manufacturers to submit all drug uses 

to the FDA for approval. 13 F. Supp. 2d 

51, 54–55 (D.D.C. 1998) vacating as moot, 

Wash. Legal Found. V. Henney, 202 F.3d 

331 (D.C. Cir. 2000) (vacating the district 

court judgment after the FDA adopted the 

position that the Food and Drug Administration 

Modernization Act and the guidance 

at issue did not confer authority to 

the FDA to prohibit or to sanction speech). 

Importantly, the district court held that the 

FDA had less restrictive means available to 

achieve the substantial government interest 

of encouraging manufacturers to submit 

all drug uses to the FDA for approval 

that would not burden commercial speech; 

namely, the “full complete, and unambiguous 

disclosure by the manufacturer,” including 

a disclaimer that the FDA had not 

approved the offlabel use. Id. at 72–73. But 

see United States v. Caronia, 576 F. Supp. 2d 

385, 397 (E.D.N.Y. 2008) (holding that the 

offlabel marketing ban was constitutional 

partly because the court could not “identify 

non-speech restrictions that would 

likely constrain in any effective way manufacturers 

from circumventing the approval 

process”). Despite the different reasoning 

articulated by the court in Caronia, 

576 F. Supp. 2d at 397, the Friedman court 

instructively reasoned that full disclosure 

rather than regulation “comports with the 

Supreme Court’s preference for combating 

potentially problematic speech with more 

speech.” 13 F. Supp. 2d at 73. 

Subsequently, the Supreme Court has 

indicated a strong reluctance to condone 

regulations that burden commercial speech 

when the government has other means of 

regulation available. In Thompson v. W. 

States Med. Ctr., the Supreme Court held 

that a law that prohibited pharmacies from 

advertising compounded drugs was unconstitutional. 

535 U.S. 357 (2002). The Court 

determined that the law did not satisfy 

the forth prong of the Central Hudson test 

because “the Government… failed to demonstrate 

that the speech restrictions [were] 

not more extensive than [was] necessary to 

serve those interests.” Id. at 371 (internal 

citations omitted). Specifically, the Court 

suggested that the government could adopt 

acceptable alternatives to a commercial 

speech restriction such as limiting the volume 

of compounded drugs that a pharmacy 

could sell or limiting the percentage 

of total revenue that compounded drug 

sales could account for. Id. at 372. The FDA 

potentially could also adopt these measures 

as less restrictive alternatives to the current 

FDA ban on offlabel drug-use marketing. 

In Sorrell v. IMS Health, the U.S. Supreme 

Court determined that the First Amendment 

is hostile toward any regulation that 

places restrictions on commercial speech 

in the name of the public good. Sorrell held 

that a Vermont law that prevented pharmacies 

from selling prescription information 

to pharmaceutical companies for marketing 

purposes violated the First Amendment 

because it did not directly advance the state 

interest in protecting medical privacy and 

reducing health-care costs. Sorrell, 131 

S. Ct. at 2668. The Court declared that 

“[s]peech in aid of pharmaceutical marketing… 

is a form of expression protected by 

the Free Speech Clause of the First Amendment.” 

Id. at 2659. Specifically the Court 

wrote that “[t]he First Amendment directs 

us to be especially skeptical of regulations 

that seek to keep people in the dark for 

what the government perceives to be their 

own good.” Id. at 2670. (finding fault addi- 

Off-Label, continued on page 81 



From the Chair 

Making Great 

Greater 

By Charles A. Stewart III 

The Product Liability 

Committee started in 

the late 1970s and has 

continued to be one of 

DRI’s largest and most 

active committees. 

Despite its rich history, 

the committee never rests. 

■ Charles A. (Chuck) Stewart III is a trial lawyer, co-chair of the firm’s Product Liability Practice Group, and a founding partner of 

the Montgomery, Alabama, office of Bradley Arant Boult Cummings LLP. Admitted to the bars of both Alabama and Tennessee, 

Mr. Stewart has extensive trail experience representing national and international corporations, primarily in the areas of product 

liability, toxic torts, employment, large personal injury, and business litigation. 


My father was a product liability defense lawyer in Birmingham, 

Alabama. I remember that, in my youth, there 

was a whole list of activities that I could never participate 

in. For example, fun things like spraying lighter fluid on a 

charcoal grill were strictly prohibited at my 

house. My friends seemed to have so much 

fun doing that at their homes. And if the 

lawn was being mowed, I could not go outside. 

Lawnmowers throw rocks and cause 

grievous injuries. I remember my father 

pulling off the road and stopping the car 

until one of us re- buckled his or her seatbelt. 

I did the same with my children when 

they were growing up. They even called 

me “Danger Dad” because I was always 

warning them about the terrible fate that 

awaited them if they were careless in doing 

anything. 

And no one in our house drove a car 

before reading the owner’s manual from 

cover to cover. Have you read the owner’s 

manual for the car that you drive Have 

you read the owner’s manual for the car 

your spouse or child drives Chances are, 

if you are practicing in the area of product 

liability law, you have read them all. After 

27 years of practicing law in this area, I 

still remain flabbergasted that apparently 

no one reads owner’s manuals or warnings. 

The most conscientious plaintiffs will 

admit to having read only portions of their 

manuals. Naturally, the portion they chose 

was irrelevant to the subsequent injury. In 

September, I helped move my oldest daughter, 

Nancy—the third generation product 

liability defense lawyer in our family—into 

her apartment in Orange County, California. 

She called me one day from a gas station 

shortly after purchasing her new car. 

The conversation started like this: “Okay, 

Dad, so I haven’t read the owner’s manual, 

but can you tell me how…” Where did I 

go wrong 

Warnings topics are a fascinating part 

of product liability litigation. Back in 2007, 

this committee asked me to put together a 

compendium on the duty to warn in product 

liability cases. I turned to some of the 

best product liability lawyers in this country 

and asked them to help me put together 

a 50-state compendium on the duty to 

warn. This year, we have created the second 

version of this publication. It is entitled 

Product Liability: Warnings, Instructions, 

and Recalls. This new publication was put 

together so that there would be a comprehensive 

summary of the current U.S. common 

law, as well as international common, 

civil, and regulatory law. The publication 

addresses pre-sale warnings and post-sale 

duties to warn or fix a defective product. 

Not only does the publication address all 

50 states, but we have also called upon firstrate 

DRI lawyers from outside the U.S. to 

assist in putting together an international 

publication. Ken Ross was the driving force 

behind this second edition. 

The Product Liability Committee started 

in the late 1970s and has continued to be 

one of DRI’s largest and most active committees. 

Committee members have published 

and spoken on virtually every aspect 

of product liability litigation. They have put 

together some of the very best seminars 

that DRI has sponsored. Despite its rich 

history, the committee never rests. We are 

always looking for new topics for seminars, 

periodical articles, and compendia. 

The leadership of the Product Liability 

Committee consists of the very best that 

the defense bar has to offer. There are 18 

specialty law groups. These specialty law 

groups focus on specific areas of product 

liability law, including Agricultural, Construction 

Mining & Industrial Equipment; 

Automotive; Aviation & Aerospace; Biomechanics 

& Injury Causation; Building Products; 

Chemical & Toxic Tort; Children’s 

Products; Consumer Goods & Office Equipment; 

e- Discovery; Fire & Casualty; Food 

Law; Hand & Power Tools; International; 

Manufacturers’ Risk; Mass Torts & Class 

Actions; Recreational Products; Scaffolds, 

Cranes & Aerial Devices; Trial Techniques, 

and Technology. 

When we put together our annual seminars, 

we focus on providing first-rate mainstage 

speakers. In addition, throughout the 

seminar, we schedule breakout sessions for 

each of our specialty law groups to focus on 

those issues that are important to them. 

Next year’s Product Liability Conference 

in National Harbor, Maryland, will be no 

different. Our program chair, Anne Talcott, 

and co-chair, James Weatherholtz, have 

worked hard to put together a terrific program. 

We will have regulators from NTSB, 

NHTSA, FDA, and CPSC. Our proximity 

to the nation’s capital gave us the opportunity 

to include these regulators. We are 

also inviting our clients to serve on panels 

alongside the regulators to give perspective 

to the topics. These practical sessions will 

be invaluable for you and your practice. I 

am extremely excited about this program 

having top national product liability trial 

lawyers and an experienced jury consultant 

demonstrate various techniques for trial. 

At the end, these product liability lawyers 

will demonstrate their skills at giving 

closing arguments. These closings will use 

a hypothetical fact pattern that is woven 

throughout the main stage talks. These 

attorneys will not be permitted to view the 

other attorneys as they give their closing 

arguments. Mock jurors will be present. 

Our jury consultant will wrap up the seminar 

providing discussion, evaluation, and 

analysis of how the trial lawyers perform. 

So, not only will attendees be brought up 

to date on all current trends, but they will 

also observe masterful trial lawyers and 

their techniques. The seminar provides up 

to 18.75 credit hours including one hour of 

ethics credit. 

As with all Product Liability Conferences, 

there will be counsel meetings, a 

business meeting of this committee, and 

various networking opportunities. Please 

mark your calendars for April 3–5, 2013. 

Plan on joining us for a fantastic program. 

If you are already a member of our committee, 

I hope that you will become more 

involved. There is plenty of work to do 

on this committee, including publishing, 

speaking, helping with membership, and 

assisting in the planning of our future seminars. 

If you are not already a member, I 

encourage you to join the Product Liability 

Committee. Spend some time on DRI’s 

website and look at the various opportunities 

that are available to you. Our leadership 

roster is posted on the Internet. If 

you find something that interests you, call 

me or the leader in charge of that group 

Greater, continued on page 82 



Asbestos Litigation 

By Tanya M. Lawson 

Successor 

Liability and 

Current Trends 

To guarantee longterm 

viability, successor 

companies must continue 

the delicate dance 

required to protect 

against tort liability that 

they did not create. 

Those familiar with the mammoth that is asbestos litigation 

are aware of the many challenges that defendant 

companies face, not the least of which include runaway 

verdicts and substantial litigation costs. Many companies 

have taken draconian steps to limit costs 

and have sought ways to exit this litigation, 

whether graciously or not, to avoid 

the least gracious exit of all, bankruptcy— 

an exit that this litigation has forced many 

before to take. 

At the same time, resourceful plaintiffs’ 

attorneys have explored alternative ways 

to expand liability to companies that never 

manufactured or distributed asbestos 

products. These defendants may have had 

minimal connections to the now- defunct 

companies that manufactured and sold 

asbestos, but plaintiffs’ attorneys have used 

traditional and other evolving exceptions 

to the rules of successor liability to take 

aim at these defendants, sometimes successfully. 

In August of this year, a plaintiff 

in Texas sued Kraft Foods North America 

Inc. for damages associated with her husband’s 

exposure to asbestos while working 

for a Kraft Foods predecessor. The net 

of asbestos litigation has broadened rather 

than contracted, defying expectations, and 

it has continued to broaden, forcing companies 

that were not previously caught in 

the web of asbestos to join the fray. 

Against this backdrop policymakers 

have expended some effort to find ways 

to protect companies that acquired other 

companies with direct or tangential links 

to the asbestos industry, and some states 

have enacted legislation intended to limit 

this liability. Crown Cork & Seal Co.’s experience 

highlights the dilemma faced by successor 

companies that led to this legislative 

response. 

The Crown Cork & Seal Dilemma 

Crown Cork & Seal, which never manufactured 

or sold asbestos products, was one of 

many defendants sued by Barbara Robinson 

and her husband John Robinson after he 

was diagnosed with mesothelioma. See Robinson 

v. Crown Cork & Seal Co., 335 S.W.3d 

126 (Tex. 2010). Crown was sued as a successor 

to Mundet Cork Corporation, which 

manufactured asbestos insulation to which 

■ Tanya M. Lawson is a partner in the Fort Lauderdale, Florida, office of Sedgwick LLP. She defends clients sued due to injuries 

sustained from allegedly defective products and has extensive experience defending asbestos claims in Florida as well as in 

the asbestos multidistrict litigation in the Eastern District of Pennsylvania. The author wishes to thank Sedgwick attorneys Lenore 

Smith, Vacharaesorn Vivacharawongse, and Keshia Rodriguez for their contributions to this article, and summer associates, 

Freddy Munoz and Jewell Riddick for their research assistance. 


John Robinson was allegedly exposed while 

he served in the United States Navy. 

In 1963, Crown’s predecessor acquired 

a majority of the stock in Mundet. Within 

a few months Mundet sold all its assets 

related to insulation, and two years later, 

in February 1996, Mundet and Crown 

merged. Crown acknowledged that as a 

successor it succeeded to Mundet’s liabilities 

under traditional successor liability 

principles. Although Crown acquired Mundet 

for only around $7 million, by the early 

2000s, Crown had paid over $400 million 

in asbestos settlements, and Mundet’s 

insurance coverage totaled about $3.7 million. 

To say the least, Crown executives 

suffered buyer’s remorse. This was not, 

however, either the first or the last time 

that a successor company has been saddled 

with the weight of costly asbestos litigation. 

Many companies 

have structured their 

acquisitions carefully 

to minimize liability for 

product defects that may 

be associated with a 

predecessor’s product. 

Successor Liability Theories 

Used in Asbestos Litigation 

Under traditional principles of corporate 

law, the nature of a transaction determines 

whether a corporate successor assumes the 

liabilities of its predecessor. If the parties 

transfer the corporate enterprise through 

a merger or a consolidation, the successor 

assumes the predecessor’s liabilities, 

including product liability claims. If the 

successor purchases the assets of the predecessor, 

however, the successor does not 

assume the predecessor’s liabilities unless 

(1) the successor expressly or impliedly 

assumes those liabilities; (2) the transaction 

is a de facto merger; (3) the successor 

is considered a “mere continuation” of the 

predecessor; or (4) the successor executed 

the transaction fraudulently to escape liability. 

Call Ctr. Techs., Inc. v. Grand Adventures 

Tour, 635 F.3d 48, 52 (2d Cir. 2011); 

Patin v. Thoroughbred Power Boats, 294 

F.3d 640, 649 (5th Cir. 2002). 

Knowing the risks associated with 

merging with companies involved in the 

asbestos industry, many companies have 

structured their acquisitions carefully to 

minimize liability for product defects that 

may be associated with a predecessor’s 

product. Structuring a deal as an asset purchase 

rather than as a merger or a stock 

purchase is one method that companies 

have used to try to avoid the tort liabilities 

of predecessor companies. Even though 

companies may structure their transactions 

as asset purchases, however, they 

may still find themselves holding the bag if 

plaintiffs can prove that one of the exceptions 

to excusing successor liability applies. 

In Schmoll v. ACandS, Inc., 703 F. Supp. 

868 (D. Or. 1988), the court found that 

although the asset restructuring of 

Raybestos- Manhattan, Inc., a manufacturer 

of asbestoscontaining products, met 

the technical formalities of corporate form, 

the restructuring was designed with the 

improper purpose of escaping asbestosrelated 

liabilities. In that case, Raymond 

Schmoll brought a products liability action 

for alleged exposure to asbestos from products 

manufactured by the defendants, including 

Raymark Industries, Inc., which 

manufactured and distributed asbestoscontaining 

energy absorption and transmission 

products. In the 1970s, Raymark 

Industries, previously known as Raybestos- 

Manhattan, Inc., was named in an everincreasing 

number of asbestos cases and, 

as a result, suffered a precipitous decline 

in net worth. Through a complicated series 

of transactions taking place over a six-year 

period, Raymark Corporation, a holding 

company that operated through its subsidiary, 

Raymark Industries, reorganized its 

corporate structure, ultimately transforming 

Raybestos Manhattan into Raymark 

Industries and Raytech. In doing this, 

ownership of the two historically lucrative 

businesses of Raymark Industries was 

transferred to Raytech, and other restructuring 

efforts freed Raytech of the drain of 

the asbestos litigation. 

Schmoll took the position that Raytech 

should be held liable for Raymark Industries’ 

production, sale, and distribution of 

asbestoscontaining products because Raytech 

and Raymark Industries were one and 

the same corporate entity. The court stated 

that the defendants and their counsel “engineered 

an elaborate, apparently unique 

transfer of corporate assets” but that both 

the “context of the corporate restructuring 

and the participants’ statements show[ed] 

that the elaborate transfer of assets was designed 

to escape liability.” Id. at 873. The 

court looked closely at the financial issues 

facing Raymark Industries at the time of 

the restructuring, the backlog of asbestos 

cases pending against Raymark Industries, 

the total value of the pending claims 

and damages awarded, and the high percentage 

of its insurance coverage already 

used. The court also looked at statements 

made to shareholders about the purpose of 

the restructuring, which included the desire 

to protect shareholder investment and limit 

exposure for asbestos claims to businesses 

currently threatened. After completing the 

analysis the court held that there was no 

reason to respect the integrity of the transactions 

because it was clear that they were 

designed with the improper purpose of escaping 

asbestosrelated liabilities. 

Traditional Exceptions 

Successor liability has served as both a 

sword and as a shield in asbestos litigation, 

depending on the circumstances. In 

a traditional context, plaintiffs have sued 

successor defendants when the original 

manufacturer of the a product at issue no 

longer existed; when it was unclear which 

one was the responsible entity, the predecessor 

or successor; or when the successor 

simply was the lower hanging fruit due 

to accessibility or solvency. In those situations, 

the plaintiffs have had to prove 

that one of the four previously enunciated 

exceptions to the rule excusing successor 

liability applies. The rules in play vary from 

state to state, and which state’s law applies 

will play a significant role in determining 

whether a company does or does not have 

asbestosrelated successor liability. 

Many states have at minimum adopted 

the four traditional exceptions to excusing 

successor liability. However, plaintiffs’ 

attorneys in asbestos cases typically focus 

on the de facto merger and mere continu- 



ation exceptions when trying to establish 

that successor liability should apply. 

The focus of the de facto merger analysis 

is on the similarity of business operations 

of the predecessor and the successor companies. 

If a successor retains continuity of 

certain aspects of the predecessor company’s 

general business operations and obligations, 

such as management, personnel, 

Which state’s law 

applieswill play a 

significant role in 

determining whether a 

company does or does 

not have asbestosrelated 

successor liability. 

business location and shareholders, and 

the two companies reasonably promptly 

dissolved the predecessor’s business operations, 

a court likely will find that the 

two companies executed a de facto merger. 

See Philadelphia Electric Co. v. Hercules, 

Inc., 762 F.2d 303, 310 (3d Cir. 1985); T.H.S. 

Northstar Assocs. v. W.R. Grace & Co., 840 F. 

Supp. 676 (D. Minn. 1993). Although courts 

have developed a four-part test incorporating 

these factors to assess whether a de facto 

merger exists, the analysis is less than scientific, 

and how a court will rule is not easy 

to predict. Indeed, several Minnesota courts 

have issued conflicting opinions on whether 

the acquisition of Zonolite Company by 

W.R. Grace resulted in successor liability. 

In T.H.S. Northstar Associates, Northstar 

claimed that it had been forced to remove 

and replace Monokote asbestos fireproofing 

at considerable cost and that W.R. Grace 

should be held liable for those costs as a successor 

in interest to Zonolite Company. Under 

the purchase agreement, W.R. Grace 

acquired substantially all of Zonolite’s properties 

and assets, including its business as 

a going concern, its name, know-how, formulas, 

and contracts, in exchange solely 

for a small part of the common stock of 


W.R. Grace. Under the agreement Zonolite 

was to dissolve and liquidate as soon as 

practicable after closing the deal, and W.R 

Grace assumed all Zonolite’s debts and liabilities 

existing on the date of the closing. 

W.R. Grace argued that the transaction was 

an asset purchase rather than a merger because 

Zonolite remained in business for 17 

months after the closing and retained assets 

of over $200,000. Furthermore, even 

though the agreement required W.R. Grace 

to retain Zonolite’s president for five years, 

W.R. Grace did not add any Zonolite representatives 

to its board, and Zonolite shareholders 

held a mere 2.27 percent of W.R. 

Grace’s stock after the acquisition. Despite 

that in an earlier Minnesota district court 

decision in East Prairie R-2 School District 

v. U.S. Gypsum Co., 813 F. Supp. 1396 (E.D. 

Mo. 1993), the court found that W.R. Grace 

was not a successor in interest to Zonolite, 

the Northstar court held that the evidence 

satisfied each element of a de facto merger, 

thereby making W.R. Grace liable for the 

cleanup associated with Zonolite’s asbestoscontaining 

fireproofing under Minnesota 

law. The Northstar court viewed the East 

Prairie court’s application of the de facto 

merger doctrine as too narrow; the East 

Prairie court grounded its decision in two 

facts: “the small percentage of W.R. Grace 

shares held by former Zonolite stockholders 

and the lack of mutual officers and directors.” 

The Northstar court, instead found the 

continuity of shareholders, rather than the 

percentage of ownership, more significant 

to a finding of a de facto merger. The court 

also found it important that Zonolite did 

not remain at arms’ length with W.R. Grace 

after the litigation, but instead W.R. Grace 

created a “Zonolite Division” and continued 

the operations of Zonolite through the use 

of its expertise and personnel. 

The mere continuation exception to the 

rule against successor liability in asset purchases 

is based on the premise that despite 

the change in name and other characteristics 

the successor corporation has in 

essence the same identity as the predecessor 

corporation. Tift v. Forage King Indus., 

Inc., 322 N.W.2d 14, 16–17 (Wis. 1982); 

Sculptchair, Inc. v. Century Arts, Ltd., 94 

F.3d 623, 630 (11th Cir. 1996); Bud Antle, 

Inc. v. Eastern Foods, Inc., 758 F.2d 1451, 

1458 (11th Cir. 1985) (a “mere continuation 

of business” will be found where the purchasing 

corporation is merely a “new hat” 

for the seller with the same or similar management 

and ownership). 

Unlike the de facto merger exception, 

the authors have not identified a widely 

accepted formula listing the elements that 

courts must identify to determine whether 

a successor corporation merely continued 

the operations of the predecessor. Instead, 

courts have considered various factors 

when trying to identify business continuity, 

including the circumstances surrounding 

the successor’s purchase of the assets 

of the predecessor and the degree of continuity 

between the shareholders, directors, 

and officers of the successor corporation 

and the predecessor. 

Evolving Theories of Successor Liability 

Courts traditionally have applied the de 

facto merger or the mere continuation 

exceptions in product liability cases very 

narrowly and reluctantly. As a result, other 

theories of successor liability have evolved 

that have provided more fertile ground for 

asbestos plaintiffs in jurisdictions that have 

adopted them. 

The continuous enterprise exception was 

developed as a way to broaden the restrictive 

mere continuation exception. It emphasizes 

continuation of the entire business 

operation rather than the mere continuity 

of the corporate entity. Courts consider 

factors such as (1) whether there is a basic 

continuity of the enterprise of the seller 

corporation, including the retention of key 

personnel, assets, general operations, and 

corporate name; (2) whether the seller corporation 

ceases business operations, liquidates, 

and dissolves soon after the sale; 

(3) whether the purchasing corporation assumes 

those liabilities and obligations of the 

seller that are ordinarily necessary for continuing 

the normal business operations of 

the seller corporation; and (4) whether the 

purchasing corporation holds itself out as 

in effect a continuation of the seller corporation. 

Courts that have supported the development 

of this doctrine have reasoned 

that this approach places the risk associated 

with a defective product on the manufacturer 

rather than the consumer, and 

the successor corporation should be made 

to bear some of the burden of its predecessor 

after receiving the benefit of continuing 

the predecessor’s business.

Another nontraditional exception 

adopted in some jurisdictions is the 

product- line exception first enunciated in 

Ray v. Alad Corp., 560 P.2d 3 (Cal. 1977). 

This exception applies to a purchasing corporation 

that continues to produce and to 

sell the line of products previously manufactured 

and sold by the predecessor corporation, 

imposing successor liability on that 

purchasing corporation. Some courts may 

find successor liability even if the successor 

was not involved in the manufacture or the 

distribution of the defective product but 

the successor purchased substantially all 

the manufacturing assets and undertook 

essentially the same manufacturing operation 

as the selling corporation. Ramirez 

v. Amsted Indus., Inc., 431 A.2d 811 (N.J. 

1981). The analysis reviews whether (1) the 

successor corporation has acquired all of 

the predecessor’s assets, leaving no more 

than a mere corporate shell; (2) whether 

the successor has held itself out to the general 

public as a continuation of the predecessor 

by producing the same product line 

under a similar name; and (3) whether the 

successor has benefitted from the goodwill 

of the predecessor. Martin v. Abbott Labs, 

689 P.2d 368, 387 (Wash. 1984). 

While the traditional theories of successor 

liability were developed in the 

framework of the law of corporations, the 

product- line exception emerged as a way 

for courts to find successor liability in 

the framework of product liability litigation. 

The court in Ray found the following 

considerations supported the decision to 

expand the exceptions to the rule against 

successor liability: (1) the successor’s 

acquisition of the business almost entirely 

destroyed the plaintiff’s remedies against 

the original manufacturer; (2) the successor 

had the ability to assume the original 

manufacturer’s risk- spreading model; and 

(3) it appeared fair to require the successor 

to assume responsibility for defective products 

as a burden of enjoying the original 

manufacturer’s goodwill, which the successor 

did enjoy in continuing to operate the 

business. Ray, 560 P.2d at 8–9; see also Garcia 

v. The Coe Mfg. Co., 933 P.2d 243, 248– 

50 (N.M. 1997) (adopting the product- line 

exception); Martin v. Abbott Labs., 689 P.2d 

at 388 (same). 

Not all jurisdictions have adopted the 

product- line exception to the rule against 

successor liability, and some will focus only 

on the four traditional exceptions. Currently, 

only a minority of courts takes the 

product- line approach, and several courts 

have expressly declined to adopt it, reasoning 

that expanding successor liability 

through this approach belongs to the legislatures 

and not to the courts. See, e.g., 

Semenetz v. Sherling & Walden, Inc., 851 

N.E.2d 1170 (N.Y. 2006); Winsor v. Glasswerks 

PHX, LLC, 63 P.3d 1040 (Ariz. Ct. 

App. 2003)); Downtowner, Inc. v. Acrometal 

Prods., Inc., 347 N.W.2d 118 (N.D. 1984). 

Armed with the traditional and emerging 

exceptions to the rule against successor liability 

in asset transactions, plaintiffs’ attor- 

Forensic Engineering 

Forensic Architecture 

Industrial Hygiene & Safety 

Fire & Arson Investigation 


Investigation & Analysis 

Construction, Design & 

Materials Defects Forensics 

Cost Estimating 

EXPERT 

FORENSICS 

EXPERT 

SOLUTIONS 

Nelson Architectural Engineers, Inc. 

(NAE) is a globally recognized 

forensics and consulting 

firm specializing in 

Forensic Engineering, 

Forensic Architecture, 

Industrial Hygiene 

and Safety, and 

Cost Estimating 

1.877.850.8765 

www.nae-us.com 



Corporate defendants 

have fought to prevent 

asbestos plaintiffs and their 

counsel from expanding 

the exceptions to the rule 

against successor liability 

and have tried to limit the 

application of the exceptions 

that currently exist. 

neys have pursued product liability claims 

against successor companies in the hopes of 

obtaining recoveries. A successor company 

also potentially faces punitive damages for 

the torts of a predecessor corporation. Oliver 

v. GAF Corp., No. 83-4208, 1985 U.S. Dist. 

Lexis 17822 (E.D. Pa. July 17, 1985). 

In the meanwhile, corporate defendants 

have fought to prevent asbestos plaintiffs 

and their counsel from expanding the 

exceptions to the rule against successor liability 

and have tried to limit the application 

of the exceptions that currently exist. 

See Gennone v. A.J. Eckert Co., No. 1:09-CV- 

968, 2010 U.S. Dist. Lexis 60663 (N.D.N.Y 

June 18, 2010); Franklin v. USX Corp., 105 

Cal. Rptr.2d. 11 (Cal. App. 2001); Catasauqua 

Area School Dist. v. Raymark Indus., 

Inc., 662 F. Supp. 64 (E.D. Pa. 1987); Reed v. 

Armstrong Cork Co., 577 F. Supp. 246 (E.D. 

Ark. 1983). Some courts have indicated, 

however, that the solution to asbestosrelated 

successor liability most appropriately 

belongs to the legislatures. 

Current Legislative Trends 

Efforts to lobby state legislatures to pass 

laws on successor asbestosrelated liabilities 

have been undertaken in various 

jurisdictions throughout the United 

States. These efforts were driven by the 

American Legislative Exchange Council 

(ALEC), which is an organization that 

worked with various companies to try to 


limit asbestosrelated liabilities resulting 

from the purchase of companies previously 

involved in some aspect of the asbestos 

industry. See Mark A. Behrens, Successor 

Asbestos- Related Liability Fairness Act, 

2005 ALEC Policy Forum 19–21. ALEC 

was the author and lobbying force behind 

the model Successor Asbestos- Related Liability 

Fairness Act (model act), a template 

for existing and proposed laws regarding 

successor asbestosrelated liabilities. 

Id. at 21–26. Some opponents refer to the 

model act as a new “corporate bailout bill” 

and take the position that the legislation 

effectively immunizes successor companies 

that acquire companies with asbestosrelated 

liabilities. Sylvia Hsieh, ALEC Puts 

the Screws to Asbestos Victims, Lawyer. 

com Blog (May 22, 2012), http://blogs.lawyers. 

com/2012/05/alec-puts-the-screws-to-asbestosvictims/ 

(last visited Sept. 24, 2012). However, 

as ALEC and corporations such as 

Crown are discovering, even though new 

successor liability laws now exist in some 

jurisdictions, several courts have declared 

aspects of the new statutes unconstitutional, 

reducing their impact. 

To date, 19 states have enacted laws limiting 

successor liability. All of the laws have 

substantially the same language limiting 

liability to the amount paid for the predecessor 

company with the asbestosrelated 

liabilities. The states that currently have 

successor asbestosrelated liability legislation 

include Alabama, Arizona, Florida, 

Georgia, Idaho, Indiana, Michigan, Mississippi, 

Nebraska, North Dakota, Ohio, 

Oklahoma, Pennsylvania, South Carolina, 

South Dakota, Texas, Utah, Wisconsin, and 

Wyoming. See Ala. Code §6-5-682 (2011); 

Ariz. Rev. Stat. Ann. §12-559, 01 (2012); 

Fla. Stat. §774.004 (2005); Ga. Code Ann. 

§51-15-4 (2007); Idaho Code Ann. §30- 

1904 (2012); Ind. Code §34-31-8-8 (2009); 

Mich. Comp. Laws §600.3001 (2012); Miss. 

Code. Ann. §79-33-5 (2004); Neb. Rev. Stat. 

§25-21,286 (2010); N.D. Cent. Code §32-46- 

03 (2009); Ohio Rev. Code Ann. §2307.97 

(2004); Okla. Stat. tit. 76, §75 (2009); 15 Pa. 

Con. Stat. Ann. §1929.1 (2012); S.C. Code 

Ann. §15-81-140 (2006); S.D. Codified Laws 

§20-9-39 (2010); Tex. Civ. Prac. & Rem. 

Code Ann. §149.003 (2003); Utah Code 

Ann. §78B-4-604 (2012); Wis. Stat. §895.61 

(2011); Wyo. Stat. Ann. §1-1-134 (2011). But 

courts have declared the laws as applied 

unconstitutional in several cases, and this 

new legislation has not necessarily offered 

the safe harbor that some have envisioned. 

The Texas Supreme Court held that that 

state successor liability law was unconstitutional 

when retroactively applied because 

it destroyed vested rights accrued in a cause 

of action that predated the enactment of 

the law. See Robinson v. Crown Cork & Seal 

Co., 335 S.W.3d 126 (Tex. 2010); Satterfield 

v. Crown Cork & Seal Co., 268 S.W.3d 

190 (Tex. Ct. App. 2008). For similar reasons, 

Pennsylvania courts have held that 

the Pennsylvania statute limiting successor 

asbestosrelated liabilities was unconstitutional 

when applied retroactively. See 

Ieropoli v. AC&S Corp., 842 A.2d 919 (Pa. 

2004); Johnson v. American Standard, 8 

A.3d 318 (Pa. 2010). 

At least eight other states have attempted, 

unsuccessfully, to pass successor asbestosrelated 

liability legislation. These states include 

California, Illinois, Massachusetts, 

Missouri, New York, Tennessee, Virginia, 

and Washington. See Successor Liability: 

Asbestos Exposure, S.B. 1667, 2007–2008 

Regular Sess. (Cal. 2008); Successor Asbestos 

Related Liability Fairness Act, S.B. 

3056, 4th Gen. Assemb. (Ill. 2006); S.B. 154, 

187th Gen. Assemb. (Mass. 2011); Successor 

Asbestos- Related Liability Fairness Act, 

H.B. 261, 94th Gen. Assemb. (Mo. 2007); 

A.B. 6861, 2009 Gen. Assemb. (N.Y. 2009); 

S.B. 249, 2011 Gen. Assemb. (Tenn. 2011); 

H.B. 629, 2010 Gen. Assemb. (Va. 2010); H.B. 

2507, 2010 Regular Sess. (Wash. 2010). In 

Minnesota, the governor vetoed the legislation. 

See Letter from Mark Dayton, Governor 

for the State of Minnesota, to The 

Honorable Michelle L. Fishbach, President 

of the Senate (Apr. 9, 2012) (vetoing Senate 

File 1236 on corporate successor liability as 

it relates to gravely serious asbestosrelated 

injuries). Governor Dayton vetoed the legislation 

due to fear that it would set a dangerous 

precedent of allowing corporations 

to escape liability, and he also believed that 

the legislation “unfairly alter[ed] Minnesota’s 

law regarding corporate successor 

liability.” Id. He further stated that “[i]t is 

contradictory to define an ‘innocent successor’ 

as a corporation that has done nothing 

wrong and yet subsequently absolve it of 

its ‘known’ liabilities.” Id. Governor Dayton’s 

rationale for vetoing the law may pro- 

Successor, continued on page 80


The Keys to Success 

By Eric L. Probst 

Defending 

30(b)(6) 

Depositions 

A satisfactory outcome 

should follow proper 

preparation, but take 

nothing for granted when 

selecting and preparing 

a 30(b)(6) witness. 

Federal Rule of Civil Procedure 30(b)(6) requires a corporation 

to designate a witness in response to a deposition 

notice that describes with “reasonable particularity” the 

topics upon which the witness will testify. More specifically, 

[i]n its notice or subpoena, a party may 

name as a deponent a public or private 

corporation,… and must describe with 

reasonable particularity the matters for 

examination. The named organization 

must then designate one or more officers, 

directors, or managing agents, or 

designate other persons who consent to 

testify on its behalf; and it may set out 

the matters on which each person designated 

will testify…. The persons designated 

must testify about information 

known or reasonably available to the 

organization. This paragraph (6) does 

not preclude a deposition by any other 

procedure allowed by these rules. 

Fed. R. Civ. P. 30(b)(6). 

Federal Rule of Civil Procedure 30(b) 

(6) has three purposes: (1) to reduce the 

difficulty that a deposing lawyer encounters 

in determining, before the deposition, 

who should be deposed; (2) to curb “bandying,” 

the practice of an entity’s deponents—officers 

or managing agents—each 

in turn offering deposition testimony denying 

knowledge of facts that people in the organization 

clearly know; and (3) to allow an 

entity to identify the corporate designee for 

the deposition when another party wants to 

depose an unnecessarily large number of 

the entity’s officers and agents because the 

deposing party does not know who has the 

relevant knowledge. Fed. R. Civ. P. 30(b)(6) 

advisory committee’s notes to 1970 amend. 

The Federal Practice Rules Committee 

comments and case law are clear that 

a 30(b)(6) deposition should be “viewed 

as an added facility for discovery,” and the 

scope, with some limitations, can be broad, 

to effect the liberal discovery goals of the 

Federal Rules of Civil Procedure. King v. 

Pratt & Whitney, 161 F.R.D. 475, 476 (S.D. 

Fla. 1995) (quoting Fed. R. Civ. P. 30(b)(6) 

and advisory committee’s notes). As with 

any other discovery device, 30(b)(6) deposition 

testimony can be used adversely 

against the corporation or for impeachment 

purposes. A.I. Credit Corp. v. Legion 

Ins. Co., 265 F.3d 630, 637 (7th Cir. 2001); 

Brazo River Authority v. GE Ionics, Inc., 

■ Eric L. Probst is principal of Porzio, Bromberg & Newman PC in Morristown, New Jersey, and a member of the firm’s Litigation 

Practice Group. He focuses his practice in the areas of complex commercial litigation, product liability, commercial transportation, 

class action, construction defect defense, professional liability defense, and consumer fraud. Mr. Probst is a member of the 

DRI Product Liability Committee and is vice chair of its Electronic Discovery Special Litigation Group. 



Once the notice lands 

on your desk, immediately 

consult with your client to 

determine whether it has a 

witness or witnesses who 

can testify on the topics. 

469 F.3d 416, 434 N. 20 (5th Cir. 2006). 

The potential trial implications of a corporate 

witness’ testimony require counsel 

to understand his or her client’s product, 

carefully examine the deposition notice 

topics, help identify the proper corporate 

designee or designees to testify, and thoroughly 

prepare designees to testify on the 

notice topics, among others. It is preparation, 

probably above all else, that ensures a 

successful 30(b)(6) deposition. 

The Deposition Notice 

The starting point is the deposition notice. 

Federal Rule of Civil Procedure 30(b) 

(6) deposition notices are different from 

fact- witness deposition notices and must 

be treated that way. The deposition topics 

must be examined carefully to determine 

whether a client can even produce a 

witness with knowledge to testify on the 

listed topics. Counsel must not misinterpret 

the threshold question. The question is 

not whether counsel understands the scope 

of the deposition topics, but rather whether 

a client’s designee understands what he or 

she will testify about. You must object to descriptions 

that are vague, ambiguous, and 

extremely broad, in writing, and well in advance 

of a deposition. Vagueness is always 

a concern. When objecting, inform a plaintiff’s 

counsel that your client will produce 

a witness to testify based on the client’s understanding 

of the deposition topics. 

Timing is key. Once the notice lands on 

your desk, immediately consult with your 

client to determine whether it has a witness 

or witnesses who can testify on the topics. 

In product cases, it often takes counsel and 

a client considerable time to identify the 


correct corporate designee or designees to 

testify. There is often a long delay between 

receiving the deposition notice and identifying 

a witness, who then needs to read 

the notice to ensure that he or she has the 

knowledge to testify. Do not wait until two 

weeks before a deposition to locate a witness 

because that leaves very little time 

either to object to the notice or to prepare 

the witness. Likewise, you cannot assume 

that your client can produce a witness at 

all, or only one witness on each of the topics. 

Multiple witnesses may be involved, including 

former employees, which may take 

your client even longer to identify. 

If you plan to object to the scope of the 

topics, and there are few occasions when 

you would not, you should object soon after 

receiving the notice to allow you and your 

adversary significant time to discuss your 

objections. If you cannot resolve your differences, 

your adversary may file a motion 

to compel the deposition, or you may be 

forced to file a motion for a protective 

order. Certain topics may be so excessively 

broad or so vague that the scope will have 

to be refined for your client before the client 

can identify the proper witness to testify. 

Court intervention may be required. 

During the Federal Rule of Civil Procedure 

16 conference, ask the magistrate 

judge how the court handles deposition 

disputes in case one occurs. Courts have 

chastised counsel for improperly terminating 

a deposition rather than seeking 

court intervention to resolve deposition 

disputes. See American General Life Ins. 

Co. v. Billard, 2010 U.S. Dist. Lexis 114961, 

*20–22 (finding that counsel “improperly 

instructed [the witness] not to answer for 

reasons unrelated to asserted privilege, and 

without immediately seeking Court intervention 

pursuant to Rule 30(d)(3).”). 

This obviously presumes that the counsel 

have a poor relationship. One of the keys 

to limiting the scope of 30(b)(6) deposition 

topics successfully is to negotiate them in 

good faith and in advance with your adversary. 

Magistrates’ scheduling orders typically 

require counsel to meet and to confer 

before raising a discovery dispute. Although 

sometimes it is nearly impossible to establish 

a good working relationship with your 

adversary, when you and your adversary do 

have one, try to resolve scope and vagueness 

issues in a notice before a deposition 

begins. This should ensure that a deposition 

proceeds more smoothly for your witness. 

Counsel should not automatically 

assume that a 30(b)(6) deposition is the 

most appropriate discovery tool for a plaintiff’s 

attorney to use to discover information 

about the topics listed in a deposition 

notice. TV Interactive Data Corp. v. Sony 

Corp., C-10-475, 2012 U.S. Dist. Lexis 56861 

(N.D. Cal. Apr. 23, 2012). In TV Interactive, 

a patent dispute case, the plaintiff, TV 

Interactive, sought the factual basis of the 

defendant’s, Funai, affirmative defenses 

and legal claims. Id. at *8–9. Using a 30(b) 

(6) deposition to question someone who 

was not a lawyer about the defendant’s 

legal positions troubled the court, especially 

in a patent dispute. Id. at *11 (quoting 

McCormick- Morgan, Inc. v. Teledyne 

Indus., Inc., 134 F.R.D. 275, 287 overruled 

on other grounds, 765 F. Supp. 611 (N.D. Cal. 

1991)). The court ultimately held that contention 

interrogatories, rather than 30(b) 

(6) depositions, were more appropriate discovery 

tools for obtaining the factual bases 

for the defendant’s affirmative defenses. Id. 

Therefore, TV Interactive teaches that 30(b) 

(6) depositions require more exacting scrutiny 

than we probably give them. 

Witness Selection 

Choosing the correct corporate witness designee 

to testify is important because the 

witness is the face of a corporation, and the 

deposition testimony, which counsel will often 

videotape, will bind the corporation during 

a trial. Counsel will want to be sure that a 

witness designated to testify has knowledge 

of the deposition topics that not only satisfies 

the corporation’s obligation under the Federal 

Rule of Civil Procedure 30(b)(6), but also 

will deliver an excellent deposition and, in 

turn, make a good trial witness. Therefore, 

several issues must be examined before selecting 

a corporate designee. 

Previous Testimonial Experience 

The first question to ask is, “Has the witness 

testified before” If the answer is yes, 

the next question is, “Is that a good or a 

bad thing” The answer to that question depends 

on the witness. Some corporate designees 

are skilled deposition witnesses. They 

do not require significant hand- holding 

or preparation and can represent themselves 

and a corporation even against the

most skilled questioner. However, numerous 

deposition transcripts will exist for the 

serial deponent and offer a plaintiff’s attorney 

ample cross- examination material. So 

read these first after searching for them and 

before designating a witness. On the other 

hand, a first-time witness requires more 

preparation time, which means additional 

cost, a significant issue in today’s world. 

Jury Appeal 

Even though most cases settle, defending 

counsel should always consider a deponent’s 

potential to appeal to a jury. The analysis 

is no different from deciding whether 

to call a witness during a trial. If a plaintiff 

alleges warning defect claims, evaluate 

whether your client’s warning witness will 

communicate the reasons why the company 

chose to design the warning the way it did 

effectively. Similarly, can a company’s design 

engineer in a design- defect case involving 

complex engineering issues explain to 

a jury how the product was designed, what 

risks the company evaluated, rejected, and 

accepted, and how the company conducted 

feasibility and alternative- design studies If 

these witnesses are skilled communicators 

who can teach a jury about a product, designate 

them as 30(b)(6) witnesses. However, 

if not, work with a client’s in-house counsel 

to identify the witness or witnesses who 

can serve in the role. 

Temperament 

Similarly, you should evaluate a witness’ 

temperament, appearance, and likeability. 

You would never put certain employees on 

the witness stand for a variety of reasons. 

They are generally unlikeable, do not have 

jury appeal, and do not communicate well, 

among other things. Therefore, you should 

not designate them as 30(b)(6) witnesses. If 

a plaintiff’s counsel is aggressive, consider 

whether your client’s witness’ personality 

will handle or succumb to the aggressive 

tactics, always remembering that the witness 

potentially will testify before a jury. 

The last thing that you want is for a witness 

to lose his or her cool and to come across 

poorly during a deposition. 

Person with the Most Knowledge 

vs. Prepared Knowledge 

In a product liability action, the knee-jerk 

reaction in choosing a 30(b)(6) witness is to 

select the engineer involved in the manufacture, 

design, or warning of the product. 

While a natural reaction, counsel should 

first reread the deposition notice to make 

sure that it seeks testimony about the manufacture, 

design, and warning of the product 

that this witness can provide. It is 

important to note that the rule allows a corporate 

defendant to designate more than 

one witness to testify on the noticed topics. 

Fed. R. Civ. P. 30(b)(6) (“then designate one 

or more officers”); King, 161 F.R.D. at 476. 

Sometimes choosing multiple witnesses 

to testify on a product’s manufacturing or 

design history can work best. Next, will 

the witness with the most knowledge— 

the engineer—make the most effective 

witness As already mentioned, you want 

to pay attention to a witness’ temperament 

and potential to appeal to a jury. If the witness 

with the most knowledge, no matter 

his or her position, will not be an effective 

witness, then educate another corporate 

employee to testify. Or, for instance, have 

an engineer testify only on limited topics, 

limiting the damage that he or she might 

do because he or she cannot communicate 

what he or she knows effectively. 

Witness Involvement with a Product 

Another compelling consideration is the 

witness’ involvement, even if remote, with 

a product. Before selecting a witness, you 

should review the relevant documents 

thoroughly to determine whether the witness 

authored any of the “bad company 

documents.” The answer to this question 

may influence your witness selection decision. 

An author- turned- witness may be in 

a better position to explain a “bad” document 

than a witness who did not author 

the document. However, someone other 

than an author may have the ability to 

answer questions about the correspondence 

because he or she did not draft it and 

might feel less defensive about the contents, 

allowing the witness to testify more comfortably 

about it. 

Warning- defect cases are especially difficult. 

The potential witness with the most 

knowledge almost always is the engineer 

who designed the warning. Before producing 

this witness, every document, including 

electronically stored information, 

should be located and reviewed to determine 

whether an opponent can cross- 

examine the witness with damaging 

documents. Does an engineer have notes 

or diagrams that did not make it into the 

relevant project file Are they damaging 

Remember, a client will have to produce 

these documents if it relies on them to prepare 

for a deposition, assuming that the client 

did not already need to produce them in 

response to a plaintiff’s document request. 

The witness is the face 

of a corporation, and the 

deposition testimony, 

which counsel will often 

videotape, will bind the 

corporation during a trial. 

Similarly, does a potential witness have 

“product pride” All corporate witnesses 

will take a certain pride in their company’s 

product and believe that the company 

“did no wrong,” or they often believe that 

a plaintiff misused a product in an unforeseeable 

manner, maybe even recklessly, 

and disregarded the product’s warnings. 

This “pride” can become problematic when 

a witness fights with an opposing counsel 

during a deposition. Always admonish a 

witness during preparation that the goal of 

a deposition is not to win a case but just to 

get in the car at the end of the day without 

having torpedoed the case. Because you do 

not want a witness’ pride to hinder a deposition’s 

success, do not hesitate to be firm with 

the witness during deposition preparation. 

Current or Former Employee 

The rule requires a corporation to produce 

a witness with “information known or reasonably 

available to the organization.” Fed. 

R. Civ. P. 30(b)(6). That witness, at times, 

may be a former employee if the information 

that the former employee has is “reasonably 

available” to the corporation and 

a current employees does not possess the 

former employee’s knowledge base or can 

become educated sufficiently to testify. 

Certain issues are associated with desig- 



nating a former employee to testify—compensation, 

costs, expenses, the relationship 

with the former employer, and “pride in 

the product,” are just some. These issues 

must be addressed before a corporation can 

select a former employee to testify. 

Other Factors 

Consider several factors before deciding 

The last thing that you 

want is for a witness to 

lose his or her cool and 

to come across poorly 

during a deposition. 

which witness to select. Today, deposition 

preparation legal fees and expenses are significant 

concerns for in-house counsel. Selecting 

a witness with the “most knowledge” 

typically results in less preparation time, 

and therefore, less cost because the witness 

does not need educating about the product. 

On the other hand, selecting a witness who 

will testify based on “prepared knowledge” 

will require more deposition preparation 

sessions and result in more legal fees. Time, 

or a witness’ schedule, is another factor, as 

well as other resources that affect deposition 

preparation sessions—location of the 

witness, location of the product, and the location 

of the accident scene. For example, 

you may need to decide if you want to prepare 

a witness at an accident scene so that 

the witness can inspect it. All of these factors 

have to be balanced, however, against 

the most important factor of all: whether a 

witness will be an effective witness. 

Preparation 

“Before anything else, preparation is 

key.” —Alexander Graham Bell 

Preparing for a 30(b)(6) deposition is key. 

You must prepare two people: yourself and 

the witness. 

Educating Yourself 

Before counsel can adequately defend a 

witness—indeed, before counsel can 


competently and diligently represent a 

client abiding by Model Rules of Professional 

Conduct 1.1 and 1.3—counsel must 

understand how the product works, was 

manufactured, was designed, and allegedly 

caused a plaintiff’s injury, as well 

as the warnings accompanying the product. 

Without this knowledge base, a lawyer 

defending a company witness will not 

be able to communicate with the witness 

effectively during the deposition preparation 

session or properly prepare the witness 

for the deposition. 

It is critical that counsel understand the 

product. Visiting a manufacturing facility 

offers an excellent opportunity for counsel 

to learn how a product was designed and 

manufactured. But when making a visit is 

not feasible, counsel needs to discuss the 

manufacturing, design, and warning processes, 

applicable regulatory framework, 

and distributor relationships with “business 

people” before beginning to prepare a 

witness for a deposition, before answering 

a complaint, and certainly before serving 

a discovery request. Counsel also needs to 

become educated on a product’s accident, 

recall, and litigation history to prepare a 

witness for questions on these topics. In 

essence, counsel has to “talk the talk” with 

a corporate designee witness. 

Educating a Witness 

A corporation has an obligation to educate 

a corporate witness so that the witness 

becomes knowledgeable about the topics in 

a deposition notice. King, 161 F.R.D. at 476. 

A corporation has an obligation to produce 

a knowledgeable witness because it controls 

who it designates. Id. This obligation 

stems from one of the purposes of the rule: 

to assist parties uncertain about whom has 

the relevant knowledge in the organization. 

Fed. R. Civ. P. 30(b)(6) advisory committee’s 

notes to 1970 amend. This obligation 

extends to all the topics contained in 

a deposition notice. Poole ex rel. Elliot v. 

Textron, Inc., 192 F.R.D. 494, 504 (D. Md. 

2000) (“Upon notification of a deposition, 

the corporation has an obligation to investigate 

and identify and if necessary prepare 

a designee for each listed subject area 

and produce that designee as noticed.”). 

The witness must be prepared to testify 

not only on subjects about which he or she 

has personal knowledge, but also on subjects 

about which he or she may not have 

personal knowledge. This is the essence 

of a 30(b)(6) deposition. Buycks- Roberson 

v. Citibank Fed. Savings Bank, 162 F.R.D. 

338, 343 (N.D. Ill. 1995). In products cases, 

many 30(b)(6) witnesses must be taught or 

educated about the manufacture, design, 

and warning selection of a product because 

companies generally divide manufacturing 

and design responsibilities for products 

among various employees. 

Start with the Relevant Facts 

The next question is, “What do I have to 

educate the witness about” Start with the 

most relevant facts in a case—facts about 

the accident or the injury. Make sure that 

a witness understands how the accident 

occurred, even if the witness will not be 

questioned about the accident or the injury. 

Context for a witness is important. He or 

she must understand how his or her testimony 

fits in the case. Next, discuss details 

about a company’s investigation of the accident 

with a witness, when the product was 

sold, and how distributors and contracts 

with distributors were involved. From 

there, probe the facts associated with how 

a product was manufactured and designed 

and how a company selected warnings. For 

certain types of product cases, other facts 

are highly relevant. For example, in workplace 

injury cases, a company’s knowledge 

of a product’s resale and retrofitting are 

important. In others, especially in pharmaceutical 

and medical device cases, a witness 

might need to understand a company’s 

relationship with overseas subsidiaries or 

affiliates, new drug applications, and warning 

labels contained in the Physician Desk 

Reference. While you can start with a deposition 

notice when educating a witness, do 

not stop there. 

The Witness with Knowledge 

One trap to avoid is thinking that you do 

not need to educate and to prepare a witness 

who has personal knowledge about a 

product’s manufacture and design as much 

as a witness who does not. While the former 

may not require as much preparation as a 

witness who lacks personal knowledge, you 

must still prepare and caution an already 

informed witness about the importance of 

a deposition. Commonly these “informed” 

witnesses will discount the need for time-

consuming preparation sessions because 

they believe that they will be able to anticipate 

every question that plaintiffs’ counsel 

will ask. This is dangerous. During preparation 

sessions, school these witnesses on the 

hazards associated with predicting or anticipating 

questions and answers and have 

them stick to the rules of depositions: listen 

to a question and answer that question only. 

Documents 

You must decide if you will show documents 

to a 30(b)(6) witness during the deposition 

preparation sessions. If so, will you 

show the witness documents produced in 

discovery, preexisting documents, or documents 

that you have created for purposes 

of the deposition, “cheat sheets” 

Each case, witness, and deposition is different, 

so an attorney must make the calls, 

knowing that an opponent can discover 

documents shown to a witness during deposition 

preparation. 

It almost goes without saying that counsel 

should not show privileged documents 

to a witness during deposition preparation 

sessions. Further, counsel should consider 

which documents to show a witness very 

selectively. A document may contain information 

that a plaintiff’s counsel does not 

know, or it may contain privileged communications 

embedded in an attachment. 

In such cases, explaining the document to 

the witness may serve a client’s interests 

and defense strategy better. However, if a 

counsel has documents that counsel will 

likely use during a trial, show them to a 

witness to ensure that usability. 

A “cheat sheet” is a document that contains 

certain facts about a case such as 

dates, times, events, a plaintiff’s injuries, 

and manufacturing and design aspects of 

the product. It is a deposition preparation 

tool that can facilitate a deposition preparation 

session, but similar to employee 

interviews (see below), it comes with its 

own dangers. At times “cheat sheets” are 

unavoidable because of the complexity 

of the facts, the breadth of the deposition 

topics, or the need for a witness to convey 

certain testimony. If “cheat sheets” 

are used, the sheet must contain only facts 

and not defense strategy because the documents 

are discoverable. Use cheat sheets 

to achieve the goal of a 30(b)(6) deposition, 

meaning use them to preserve testimony 

for use during a trial or an arbitration. 

Developing good deposition testimony is 

imperative, and if “cheat sheets” or other 

document aids are needed to accomplish 

this goal, then use them. But use them with 

an appropriate amount of caution. 

Interviews with Current or 

Former Employees 

One way around having to show a witness 

documents is to have a witness speak to 

current or former knowledgeable employees. 

This preparation method is not without 

potential pitfalls. First, the attorney- client 

privilege likely would not apply to a witness’ 

conversation with another employee. 

Therefore, counsel should be present during 

these conversations, even if by phone. 

Second, unlike documents, counsel cannot 

control what a company employee will 

reveal to a witness. A company employee 

can reveal information that even counsel 

might not know. It is important that the 

information that a witness learns is funneled 

through an attorney. 

Former Employees 

The obligation that Federal Rule of Civil 

Procedure 30(b)(6) imposes on a corporation 

requires it to produce, under certain 

circumstances, a former employee 

as a 30(b)(6) witness, or have a current 

employee speak to one or more former 

employees so that the current employee 

can testify about the information that 

the former employee possesses. A former 

employee often is the most logical choice 

for a corporate designee, especially if legacy 

documents are involved or a product was 

manufactured and designed years before 

an accident occurred. This is very common 

in workplace injury cases. For example, 

a press involved in an accident years 

after distribution may have been resold 

multiple times before the accident. And 

because many states do not have a product 

liability statute of repose, manufacturers 

remain at risk due to these types 

of lawsuits. However, a company cannot 

plead “lack of knowledge” or “unavailability 

of information” if a deponent can educate 

him- or herself by talking with former 

employees. In re Air Cargo Shipping Services 

Antitrust Litig., 2011 U.S. Dist. Lexis 

154428, at *61 (E.D.N.Y Mar. 27, 2011). See 

Brazos River Auth. v. GE Ionics, Inc., 469 

F.3d 416, 433 (5th Cir. 2006). The court in 

In re Air Cargo recognized that a corporation’s 

Federal Rule of Civil Procedure 

30(b)(6) “duty requires the responding 

party to educate its designees ‘to the extent 

matters are reasonably available, whether 

from documents, past employees, or other 

sources.’” Id. (quoting Fleurimond v. New 

York University, No. 09-cv-3739, 2011 U.S. 

If the witnesswith the 

most knowledge, no matter 

his or her position, will not 

be an effective witness, then 

educate another corporate 

employee to testify. 

Dist. Lexis 83288, at *2–3 (E.D.N.Y. July 

29, 2011)) (emphasis supplied). The court, 

upon application, ordered deposition witnesses 

to speak or to attempt to speak to 

former employees who had participated 

in the meetings or drafted e-mail communications 

that allegedly led to the alleged 

price- fixing scheme because the testifying 

witnesses did not participate in the meetings 

or draft the e-mails that led to the 

scheme. Id. at *64. 

Affiliate Corporations 

Federal Rule of Civil Procedure 30(b)(6) also 

can oblige a corporation preparing a 30(b) 

(6) witness to consult employees working for 

affiliated entities and to prepare the witness 

based on their knowledge. Sanofi-Aventis v. 

Sandoz, Inc., 272 F.R.D. 391 (D. N.J. 2011). 

In Sanofi-Aventis, a patent infringement 

matter involving the manufacture by defendant 

Sandoz of a generic drug to Sanofi- 

Aventis’ Ambien CR, Sanofi- Aventis sought 

30(b)(6) deposition testimony on activities 

performed by Sandoz’s Slovenian pharmaceutical 

affiliate, Lek Pharmaceuticals, 

in the manufacture and drug application 

process for the generic drug. Id. at 392– 

93. After analyzing the significant involvement 

that Lek had in the drug application 

process, the court focused on whether the 



Because you do not want 

a witness’ pride to hinder a 

deposition’s success, do not 

hesitate to be firm… during 

deposition preparation. 

information that Lek possessed was “reasonably 

available” to Sandoz, the corporation 

named in a 30(b)(6) deposition notice. 

Id. at 394. Third Circuit courts have relied 

on the “control” standard of Federal Rule of 

Civil Procedure 34(a) for the production of 

documents to hold that corporations must 

have Federal Rule of Civil Procedure 30(b) 

(6) witnesses obtain information from related 

entities from whom they have “the 

legal right, authority or ability to obtain 

documents upon demand.” Id. at 394 (citation 

omitted). Similarly, Third Circuit 

cases have required corporations to educate 

their witnesses about a related entity 

when the corporation obtained documents 

from the related entity for business needs, 

which happened in Sanofi-Aventis. Id. Other 

circuit courts have required the responding 

party to educate its witnesses on information 

from related entities with “eight degrees 

of ownership separation.” S.C. Johnson 

& Son, Inc. v. Dial Corp., No. 08-CV-4696, 

2008 U.S. Dist. Lexis 76320, at *2 (N.D. Ill. 

Sept. 10, 2008). In the circuits that have 

addressed the issue, the courts have compelled 

the litigating corporation to educate 

its witness or witnesses on the conduct of 

its related entity when it “had either the legal 

or practical ability to obtain information 

from its corporate affiliate.” Sanofi-Aventis, 

272 F.R.D. at 395 (citations omitted). Most 

frequently in a traditional product liability 

lawsuit, a court would compel a manufacturer 

to educate its 30(b)(6) witnesses on 

the conduct of related entities if the related 

entity played a role in the manufacture, design, 

or warning selection of a product, or 

of any of its components. However, Federal 

Rule of Civil Procedure 30(b)(6) is not absolute 

as “[t]he availability of information 

in possession of a related company turns 


on the facts of each case, in particular as 

they relate (sic) the ‘control’ standard of 

Rule 34(a).” Id. 

Mock Deposition 

No matter the size of a case, counsel should 

conduct a mock deposition. If counsel 

believes that a plaintiff’s counsel will ask 

certain questions, then ask them. If a plaintiff’s 

counsel will ask some potentially 

damaging questions, then ask them. Counsel 

needs to know ahead of time how a witness 

will respond to the critical questions 

that will be asked. If counsel does not like 

the response, tell a witness what is wrong 

with an answer’s phrasing, explain a better 

strategy to approach the question and 

to provide a response while crucially controlling 

his or her emotions, or, if needed, 

designate another witness. Moreover, you 

need to prepare your witness for questions 

beyond the scope of the deposition topics; 

therefore, it is important to educate the witness 

more generally about “the case” and 

about more than the manufacture, design, 

and warning selection associated with a 

product. Even if a deposition is limited in 

scope, you should conduct some form of a 

mock deposition to place a witness at ease. 

Sanctions 

Preparation is key partly because courts 

can impose sanctions against a corporate 

litigant that produces an unprepared Federal 

Rule of Civil Procedure 30(b)(6) witness. 

Baker v. St. Paul Travelers Ins. Co., 

670 F.3d 119, 124 (1st Cir. 2012) (“[b]e cause 

a corporation controls whom to designate 

for a Rule 30(b)(6) deposition,… the corporation 

should be subject to sanctions if 

it designates a witness who is not knowledgeable 

about the relevant facts.”). Courts 

have treated an unprepared witness as 

“constructive non appearance” under Federal 

Rule of Civil Procedure 37(d). Black 

Horse Lane Assoc., L.P. v. Dow Chem. Corp., 

228 F.3d 275, 303 (3d Cir. 2000); Resolution 

Trust Corp. v. S. Union Co., 985 F.2d 

196, 197 (5th Cir. 1993). Under Federal 

Rule of Civil Procedure 37(d)(1)(A)(i), federal 

courts have the authority to sanction 

a corporation if its 30(b)(6) witness “fails, 

after being served with the proper notice, 

to appear for [the] deposition.” Fed. R. Civ. 

P. 37(d)(1)(A)(i). In Black Horse Lane, the 

plaintiff’s 30(b)(6) witness, who was also 

suing in his individual capacity, failed to 

responsively answer deposition questions 

over several days, claimed not to know that 

he was a 30(b)(6) witness, answered evasively, 

and claimed not to have knowledge 

about the most relevant documents in the 

lawsuit that he signed. Black Horse Lane, 

228 F.3d at 303–304. See also Resolution 

Trust Corp., 985 F.2d at 197 (when asked 

whether he had knowledge about the item 

in the deposition notice, the witness replied 

“no”). The Third Circuit, relying heavily on 

several circuits’ case law, held that “when a 

witness is designated by a corporate party 

to speak on its behalf pursuant to Rule 

30(b)(6), ‘producing an unprepared witness 

is tantamount to a failure to appear’ 

that is sanctionable under Rule 37(d).” 

Black Horse Lane, 228 F.3d at 304 (quoting 

United States v. Taylor, 166 F.R.D. 356, 363 

(M.D.N.C.), aff’d, 166 F.R.D. 367 (M.D.N.C. 

1996). Therefore, it is imperative that counsel 

prepare a 30(b)(6) witness to testify. “I 

do not know” answers, especially repeatedly, 

are not acceptable under the Federal 

Rule of Civil Procedure 30(b)(6), and a 

deposing counsel can use them as evidence 

that the witness “failed to appear,” as well 

as grounds for sanctions. 

Deposition Issues—They Always 

Come Up, So Be Prepared 

Counsel must be aware of the fine line between 

proper objections under the Federal 

Rules of Civil Procedure and improperly instructing 

a witness not to answer a plaintiff’s 

counsel’s questions. Federal Rule of 

Civil Procedure 30(c)(2) states that “[a] person 

may instruct a deponent not to answer 

only when necessary to preserve a privilege, 

to enforce a limitation ordered by the court, 

or to present a motion under Rule 30(d)(3).” 

If counsel anticipates a contentious deposition, 

which counsel will likely know well 

ahead of time, counsel should seriously consider 

seeking a protective order to limit the 

deposition topics. See Baker, 670 F.3d at 119 

(limiting the deposition to topics that the 

First Circuit outlined in the remand order). 

As discussed above, seek a magistrate’s involvement 

before a deposition and after 

conferring with an adversary when the adversary 

wants a deposition to cover inappropriately 

broad or vaguely described topics. 

Courts will impose sanctions on counsel 

who terminate a deposition or instruct

their corporate designee not to answer questions 

unless the attorney does it consistent 

with the parameters of Federal Rule of Civil 

Procedure 30(c)(2). Harassment and an adversary’s 

bad-faith conduct do not justify repeated 

objections instructing a witness not 

to answer. American General Life Ins. Co. 

v. Billard, C10-1012, 2010 U.S. Dist. Lexis 

114961(N.D. Ia. Oct. 28, 2010). In Billard, the 

30(b)(6) deposition of a plaintiff insurance 

company’s designee was especially contentious, 

with a defendant counter- claimant’s 

counsel asking harassing, argumentative, 

irrelevant questions, often well beyond the 

scope of the notice, which the plaintiff’s 

counsel repeatedly instructed the insurance 

company’s designee not to answer, 

finally terminating the deposition. Id. at *3– 

8. While the court did not necessarily disagree 

that the defendant’s counsel acted in 

bad faith at times, and his questioning exceeded 

the scope of the notice, the court was 

most troubled by the plaintiff’s counsel’s 

failure to seek the court’s assistance under 

Federal Rule of Civil Procedure 30(d)(3), instead 

instructing the witness not to answer 

the questions. Id. at *20–22 (citing Smith v. 

Logansport Comm. School, 139 F.R.D. 637, 

643 (N.D. Ind. 1991) (finding that counsel 

should have stated objections on the record, 

halted the deposition, and immediately filed 

a protective order). The court, in awarding 

sanctions, held that the plaintiff’s counsel 

should have sought the court’s “immediate 

assistance” as outlined in Federal Rule 

of Civil Procedure 30(d)(3), through a simple 

phone call, rather than terminating the 

deposition. Id. at *21, 24. 

The most common deposition issue is 

whether counsel can make proper objections 

to questions “believed” to be beyond 

the scope of a deposition notice. You should 

not mistakenly believe that a deposition notice 

confines an examination, and you should 

not confine your preparation to the deposition 

notice topics. King, 161 F.R.D. at 476. The 

King court, followed by many federal circuits, 

have reasoned Federal Rule of Civil Procedure 

30(b)(6) as “best read” as meaning that 

[i]f the examining party asks questions 

outside the scope of the matters 

described in the notice, the general deposition 

rules govern (i.e., Fed. R. Civ. 

P. 26(b)(1)), so that relevant questions 

may be asked and no special protection 

is conferred on a deponent by virtue of 

the fact that the deposition was noticed 

under 30(b)(6). 

Id. at 476. Stated another way, a Federal 

Rule of Civil Procedure 30(b)(6) deposition 

notice does not limit the deposition topics. 

However, that is not to say that an attorney 

cannot object to the scope of the proposed 

questions. See TV Interactive, 2012 U.S. Dist. 

Lexis, at *8–12 (finding contention interrogatories 

more appropriate in discovery to obtain 

information about the defendant’s legal 

defense than Fed. R. Civ. P. 30(b)(6) depositions); 

Newman v. Borders, Inc., 2009 WL 

931545 (D.D.C. April 6, 2009) (relying on 

Fed. R. Civ. P. 1 to limit the plaintiff’s request 

for an additional 30(b)(6) witness 

rather than ordering the defendant to submit 

an affidavit addressing the company’s 

e-mail policies and system). Before designating 

additional 30(b)(6) witnesses or deciding 

to have another corporate designee appear 

to testify on a deposition notice topics, first 

confer with a client and then opposing counsel. 

And then if necessary, contact the court. 

FORENSIC ENGINEERING 

INVESTIGATIONS, 

EXPERT TESTIMONY 

and CONSULTING 

Conclusion 

Federal Rule of Civil Procedure 30(b)(6) 

depositions are important to product liability 

cases. Selecting the correct corporate 

witness, preparing the witness sufficiently, 

and dealing with lingering uncertainty, as 

well as handling the deposition itself, can 

lead to sleepless nights. A successful Federal 

Rule of Civil Procedure 30(b)(6) deposition 

will prevent an adversary from 

torpedoing a case. Success starts with carefully 

examining a deposition notice and 

raising appropriate deposition scope objections. 

Success next involves thoroughly 

selecting and preparing the witness. It finishes 

with a witness testifying with knowledge 

about the product; its involvement in 

the accident or the injury; and the product’s 

manufacture, design, and warning selection. 

Take nothing for granted when selecting 

and preparing a 30(b)(6) witness. If you 

prepare a witness properly, you should have 

a satisfactory outcome. 

Over 30 years of serving clients with industrial technical services, insurance claims 

or subrogation, and product liability litigation. 

AREAS OF EXPERTISE 

Fire and Explosion 

Propane and Natural Gas 

Industrial Accidents 

Materials and Process Engineering 

Building Science 

Standards and Code Consulting 

Slip and Fall Incidents 

Accident Investigation and Crash Reconstruction 

PROFESSIONAL DISCIPLINES 

Mechanical Engineering 

Metallurgical and Materials Engineering 

Electrical Engineering 

Chemical Engineering 

Forensic Architecture 

Structural Engineering 

Civil Engineering 

Geotechnical Engineering 

Call 800-538-2797 | For more information and expert profiles, visit www.CraneEngineering.com 



Something for Nothing 

By David M. Melancon 

and Kelly Brilleaux 

The Collateral 

Source Rule and 

Gratuitous Payments 

or Services 

While taking into 

consideration the law of 

the particular state, policy 

considerations should 

provide skillful defense 

attorneys with arguments 

against the collateral 

source rule’s application. 

When a plaintiff has undergone substantial and expensive 

medical care as a result of a personal injury, compensatory 

damages always become a primary disputed area. Generally 

speaking, the collateral source rule allows a plaintiff to 

recover medical costs from a tortfeasordefendant 

even when the plaintiff received 

some compensation toward those costs from 

an independent, or “collateral,” source. Despite 

the well- established common law justification 

for the collateral source rule, the 

policy reasons supporting it in a variety of 

different contexts remain important and often 

discussed in tort law. One of the more 

unsettled scenarios to which the collateral 

source rule may apply involves a gratuitous 

payment or services rendered to a plaintiff. 

Although the collateral source rule can apply 

to gratuitous payments for services—at 

least under some circumstances—in a majority 

of United States jurisdictions, many 

policy- based arguments support rejecting 

the use of the rule in this context. 

This article will provide a general overview 

of the historical development of the 

collateral source rule and its differing 

applications under various states’ laws, 

analyze the potential problems presented 

by gratuitous payments or services, and 

discuss some scenarios under which the 

collateral source rule may or may not apply. 

History of the Collateral Source Rule 

The collateral source rule first appeared 

in American tort law in the United States 

Supreme Court decision The Propeller 

Monticello v. Mollison, 58 U.S. 152 (1854). 

In The Propeller Monticello decision, which 

dealt with an admiralty action, the U.S. 

Supreme Court ultimately concluded that 

the damage award to the plaintiff should 

not be reduced by the amount of the insurance 

proceeds that the plaintiff received. 

Id. at 155. The Court reasoned that under 

well- established common law principles 

collateral benefits could not be considered 

in determining the recovery to which a 

plaintiff was entitled. Id. at 156. This position 

was ultimately adopted by the Restatement 

(Second) of Torts: “Payments made 

to or benefits conferred on the injured 

party from other sources are not credited 

against the tortfeasor’s liability, although 


■ David M. Melancon is a member and Kelly Brilleaux an associate of Irwin Fritchie Urquhart & Moore LLC 

in New Orleans. Mr. Melancon’s general civil litigation practice concentrates on the defense of complex personal 

injury and property damage claims, premises liability, product liability, pharmaceutical and medical 

device, and toxic torts. Ms. Brilleaux’s practice areas include pharmaceutical and medical device, casualty, 

and insurance defense litigation.

they cover all or a part of the harm for 

which the tortfeasor is liable.” Restatement 

(Second) of Torts §920A (1979). 

As a matter of policy, some courts have 

held that the justification for the collateral 

source rule is that “the wrongdoer should 

not benefit from the expenditures made 

by the injured party or take advantage of 

contracts or other relations that may exist 

between the injured party and third persons.” 

Wills v. Foster, 229 Ill. 2d 393, 412, 

892 N.E.2d 1018, 1029 (Ill. 2008) (quoting 

Arthur v. Catour, 216 Ill. 2d 72, 295 Ill. Dec. 

641, 833 N.E.2d 847 (Ill. 2005)). However, 

scholars have long recognized the problems 

with the collateral source rule—namely, 

that it potentially permits plaintiffs to land 

windfalls and unintentionally may punish 

tortfeasors too much. See Michael I. 

Krauss & Jeremy Kidd, Collateral Source 

and Tort’s Soul, 48 U. Louisville L. Rev. 1, 

8–9 (2009). Some scholars also have argued 

that the collateral source rule violates the 

basic tort principle of making a plaintiff 

whole by clearly sanctioning double recovery. 

Id. at 18. 

Procedurally, the collateral source rule 

is rooted in evidence and implicates a factfinder’s 

consideration of the damages to 

which a plaintiff is entitled. Specifically, the 

rule is an evidentiary doctrine that prohibits 

a tortfeasordefendant from introducing 

evidence of a plaintiff’s receipt of benefits 

from a collateral source for the same injuries 

for which the plaintiff alleges that the 

tortfeasordefendant is liable. Simmons v. 

Cobb, 2006 Pa. Super. 222, 906 A.2d 582, 

585 (Pa. Super. Ct. 2006) (quoting Collins 

v. Cement Express, Inc., 301 Pa. Super. 319, 

447 A.2d 987, 988 (Pa. Super. Ct. 1982)) 

(emphasis added). 

Not surprisingly, the way that courts in 

various states apply the collateral source 

rule varies among the states in a number 

of ways, including whether the collateral 

source rule applies to any potential claim 

by a plaintiff, whether it applies only to 

payments made by insurers, as opposed 

to other third parties, and if the collateral 

source rule does apply, whether a right 

of subrogation exists. In fact, across the 

United States, different jurisdictions have 

taken very different approaches to applying 

the collateral source rule. 

For example, in 1987, Alabama abrogated 

the collateral source rule by enacting 

Code of Alabama §12-21-45. The Supreme 

Court of Alabama clarified how this new 

provision applied and confirmed that the 

state had abrogated the collateral source 

rule in Senn v. Alabama Gas Corp., 619 So. 

2d 1320 (Ala. 1993). Similarly, Ohio passed 

legislation in 1987 that required courts to 

reduce a plaintiff’s compensatory damage 

award by the amount of collateral benefits 

received; however, the Supreme Court 

of Ohio subsequently declared the statute 

unconstitutional in Sorrell v. Thevenir, 

1994-Ohio-38, 69 Ohio St. 3d 415, 633 

N.E.2d 504 (Ohio 1994). See Christian 

D. Saine, Note, Preserving the Collateral 

Source Rule: Modern Theories of Tort Law 

and a Proposal for Practical Application, 

47 Case W. Res. L. Rev. 1075 (1997). Ohio 

law now provides that unless an insurer 

in question has a right of subrogation, the 

collateral source rule does not apply. See 

Ohio Rev. Code Ann. §2315.20(A) (2004). 

Conversely, the majority of the states have 

adopted the collateral source rule, albeit 

with some limitations depending on the 

specific circumstances. 

Although these are only a few examples 

of how the general purpose of the collateral 

source rule varies among the states, 

a number of more precise issues arise in 

the context of its application. One particular 

scenario that invokes policy arguments 

from both perspectives—and, accordingly, 

results in varying applications among the 

states—is the use of the collateral source 

rule in the context of gratuitous payments 

or services rendered to the plaintiff. 

Application of Collateral Source Rule 

to Gratuitous Payments or Services 

The majority of states apply the collateral 

source rule to gratuitous payments or services 

in the same manner as they apply it to 

other types of collateral payments such as 

insurance benefits. The states that clearly 

hold that the collateral source rule applies 

to these payments include, among others, 

Arizona, Arkansas, California, Georgia, 

Hawaii, Kansas, Maine, Maryland, Massachusetts, 

Mississippi, North Carolina, 

South Carolina, Tennessee, Wisconsin, 

and Wyoming. These jurisdictions appear 

to reason that regardless of the source of 

the payment, in a damages calculation a 

tortfeasor should never profit because of 

a payment received by a plaintiff from a 

third party. In many of these states the 

courts emphasize that the collateral source 

rule applies equally to gratuitous medical 

services and to benefits paid to a plaintiff. 

See, e.g., Thoreson v. Milwaukee & Suburban 

Transp. Co., 56 Wis. 2d 231, 243, 201 

N.W.2d 745, 752 (Wis. 1972). The underlying 

reason, according to the courts, is that 

a plaintiff who has been injured is entitled 

to the reasonable value of his or her 

related medical costs. The test is the reasonable 

value of the medical care, not the 

actual expenses, so whether or not there is 

an actual charge associated with the medical 

care is immaterial. Id. An additional 

reason for this view is that “the recovery 

has a penal effect on a tortfeasor and the 

tortfeasor should not get the advantage of 

gratuities from third parties.” Id. 

Of the states that apply the collateral 

source rule to gratuitous payments, however, 

some apply it more circumspectly 

than others. Compare Mitchell, Jr. v. Fortis 

Ins. Co., 385 S.C. 570, 595–96, 686 S.E.2d 

176, 189 (S.C. 2009) (“In this case, the value 

of [the plaintiff’s] free medical treatment 

is necessary to the determination of the 

amount of damage [defendant] inflicted 

upon [plaintiff] in rescinding his policy.”), 

and Guyote v. Mississippi Valley Gas Co., 

715 F. Supp. 778, 780 n.1 (S.D. Miss. 1989) 

(“The determination of whether an injured 

party could recover from the tortfeasor the 

value of medical care for which he incurred 

no expense is a question of state law. Today, 

the prevailing view is that such damages 

are recoverable.”), with Hoeflick v. Bradley, 

282 Ga. App. 123, 124, 637 S.E.2d 832, 833 

(Ga. Ct. App. 2006) (“The collateral source 

rule applies to payments made by various 

sources, including insurance companies, 

beneficent bosses, or helpful relatives.”), 

and Acordia of Virginia Ins. Agency, Inc. 

v. Genito Glenn, L.P., 263 Va. 377, 387, 560 

S.E.2d 246, 251 (Va. 2002) (“If the benefit 

was a gift to the plaintiff from a third party 

or established for him by law, he should not 

be deprived of the advantage that it confers.” 

(quoting Restatement (Second) of 

Torts §920A (1979)). 

Still other states require additional proof 

when deciding whether they will apply the 

collateral source rule to gifts or gratuitous 

services. For example, under Louisiana law, 

“a claim for sitting expenses rendered gratuitously 

by nonprofessional family mem- 



bers without a doctor’s orders must be 

viewed with close scrutiny. The need for 

the services must be shown, the reasonableness 

of the fee must be established, 

and the extent and duration of the services 

must be proven.” Tanner v. Fireman’s Fund 

Ins. Companies, 589 So. 2d 507, 515–16 (La. 

Ct. App. 1991), writ denied, 590 So. 2d 1207 

(La. 1992), and writ denied, 590 So. 2d 1207 

Defense counselhave 

several policy-based 

arguments that they can 

consider using as part of the 

overall defense of cases. 


(La. 1992) (quoting Williams v. Campbell, 

185 So. 683 (La. Ct. App. 1938)). 

Some states expressly modify by statute 

and delineate how the collateral source 

rule applies to gratuitous payments or services. 

New York, for example, enacted a 

statute that explicitly provides that a defendant 

can admit a collateral source of 

payment as evidence for the purpose of 

reducing a damages award based on the 

amount of a collateral payment and takes 

premiums into account by specifying that 

the calculation should “minus an amount 

equal to the premiums paid by the plaintiff 

for such benefits for the two-year period 

immediately preceding the accrual of such 

action and minus an amount equal to the 

projected future cost to the plaintiff of 

maintaining such benefits.” N.Y. C.P.L.R. 

§4545(a) (McKinney 2012). However, the 

statute carves out an exception for gratuitous 

payments: “[v]ol un tary charitable 

contributions received by an injured party 

shall not be considered to be a collateral 

source of payment that is admissible in evidence 

to reduce the amount of any award, 

judgment or settlement.” Id. at §4545(b). 

Other states offer less exacting direction. 

For example, Colorado’s statute reduces a 

damage award by the amount that a plaintiff 

“has been or will be wholly or partially 

indemnified or compensated for his loss 

by any other person, corporation, insurance 

company, or fund in relation to the 

injury, damage, or death sustained,” unless 

the plaintiff received the compensation as 

the result of a contract “entered into and 

paid for by or on behalf of such person.” 

Colo. Rev. Stat. Ann. §13-21-111.6 (2012). 

Although a straightforward reading of the 

statute’s language supports the conclusion 

that the collateral source rule does 

not apply to gratuitous payments or services, 

Colorado courts have held that it is 

not necessary for a plaintiff to have made 

direct payments or provided consideration 

for a contract to have benefited from it 

within the meaning of the Colorado contract 

exception to the collateral source rule. 

Tucker v. Volunteers of America Colorado 

Branch, 211 P.3d 708 (Colo. App. 2008). The 

Colorado courts have not settled whether 

the “contract exception” to the general rule 

that a fact-finder should consider collateral 

benefits when determining the amount of a 

plaintiff’s recovery subsumes the rule. 

Finally, states such as Iowa, Nevada, 

and New Hampshire do not appear to have 

addressed whether the collateral source 

rule applies to gratuitous payments or services. 

In those states, defense counsel should 

argue that the collateral source rule does 

not cover those benefits. Rather, a plaintiff 

must have paid some consideration for 

a collateral benefit for the rule to cover the 

situation. 

Potential Litigation Scenario: 

Receiving a Product Free of Charge 

Despite the already complex and varying 

ways that courts apply the collateral source 

rule to gratuitous payments or services, 

the complexity increases when a plaintiff 

receives something other than medical care 

from a family member, a donation from 

a charity, or a private or a public insurance 

write-off. Consider this scenario, for 

example: a plaintiff files a product liability 

lawsuit against a product manufacturer 

claiming that the manufacturer’s product 

caused a serious, chronic, but treatable 

medical condition or disability. The market 

cost of the treatment that the plaintiff 

needs to control the condition, which is a 

medication manufactured and sold by an 

entirely different company, is very large, 

amounting to several thousand of dollars 

each month. Fortunately for the plaintiff, 

by virtue of a need-based program sponsored 

by the pharmaceutical manufacturer, 

the plaintiff receives the medication every 

month free of charge, with no discernible 

“quid pro quo.” In short, the plaintiff 

receives the medication at no cost, and he 

or she does not have to provide anything in 

exchange. Under this hypothetical, should 

a court allow the plaintiff to introduce evidence 

of the value of the medication as part 

of his or her claimed damages What about 

the value of the medication that the plaintiff 

may receive in the future 

Arguments Against Applying 

the Collateral Source Rule 

Several policy- based arguments support 

eliminating applying the collateral source 

rule to gratuitous payments or services, 

particularly when a plaintiff has not paid 

any consideration, monetary or otherwise, 

for the benefit received, as in the abovedescribed 

hypothetical fact pattern. 

First, the plaintiff clearly would receive 

a double recovery, at least for the reasonable 

value of any medication received before 

a trial. And unquestionably, the plaintiff 

does not need a compensatory damages 

award for benefits for which the plaintiff 

never paid, and would never pay, to become 

“whole.” This argument strengthens 

when the manufacturer of the product— 

the source of the gratuitous benefit—either 

cannot or will not seek subrogation from the 

plaintiff for the value of the benefits. And, 

the plaintiff and the provider of the medicine 

have not contracted for the medicine. 

In sum, under this scenario a compensatory 

damages award that includes the cost 

of the product that the plaintiff received for 

free would produce an inequitable result. 

Second, applying the collateral source 

rule in this specific context does not necessarily 

further the policy underpinning 

the collateral source rule itself—that a 

tortfeasor should not benefit from payments 

made to a plaintiff by independent 

sources. Clearly, the plaintiff in the hypothetical 

fact pattern has not paid consideration 

for this collateral benefit—the free 

medicine, and damages recovered by the 

plaintiff for the actual cost of the drug 

would be a pure windfall. Requiring the 

tortfeasor to pay the cost of a treatment that 

the plaintiff never has absorbed would have 

an unintentional punitive aspect that tort 

law principles neither have contemplated

nor would consider equitable, particularly 

at the expensive rate of the hypothetical 

scenario offered in this article. 

A third, albeit admittedly less persuasive 

argument is that as a matter of policy 

the collateral source rule should not 

apply to nonfungible compensation. The 

collateral source rule is “aimed at preventing 

a tortfeasor from benefitting from a 

third party’s payment to the injured party.” 

Steamfitters Local Union No. 420 Welfare 

Fund v. Philip Morris, Inc., 171 F.3d 912, 

929 n.9 (3d Cir. 1999) (emphasis added). See 

also Nigra v. Walsh, 2002 Pa. Super. 113, 797 

A.2d 353, 356 (Pa. Super. Ct. 2002) (“Generally, 

‘[t]he collateral source rule provides 

that payments from a collateral source 

shall not diminish the damages otherwise 

recoverable from the wrongdoer.’” (quoting 

Johnson v. Beane, 541 Pa. 449, 664 A.2d 96, 

100 (Pa. 1995) (emphasis added))). It should 

be noted, though, that jurisprudence may 

support the application of the collateral 

source rule to goods and services in addition 

to just fungible payments. See, e.g., 

Kagarise v. Shover, 218 Pa. Super. 287, 289, 

275 A.2d 855, 856 (1971) (“‘The collateral 

source rule may be described as the judicial 

refusal to credit to the benefit of the wrongdoer 

money or services received in reparation 

of the injury caused which emanate 

from sources other than the wrongdoer.’” 

(quoting Feeley v. United States, 337 F.2d 

924, 926 (3d Cir. 1964)). Under the hypothetical 

scenario, however, the tortfeasor 

could assert that the plaintiff should not 

recover the reasonable value of the product 

that he or she received for free because the 

plaintiff received it directly from the product’s 

manufacturer, which rendered the 

value of the product irrelevant. 

Although each particular state’s law 

will affect the outcome of a defendant’s 

attempts to prevent a court from applying 

the collateral source rule to gratuitous payments 

or services that a plaintiff received 

before a trial, defense counsel have several 

policy- based arguments that they can consider 

using as part of the overall defense of 

cases. In those jurisdictions where the collateral 

source rule perhaps does not apply 

to gratuitous payments or services, defense 

counsel should consider filing a motion in 

limine. Even when a defendant cannot circumvent 

the collateral source rule entirely, 

a court can compel a plaintiff to establish 

the real need for gratuitous payments or 

services and their reasonable values. For 

example, in the litigation scenario provided 

in this article, a court should not allow the 

plaintiff simply to offer evidence of the list 

or retail cost of the medication. Rather, the 

plaintiff should have the burden of proving 

the reasonable value of the drug in the 

geographic area where the plaintiff lives 

and what the value would mean to a person 

with a similar socioeconomic background 

if the person had to purchase it. 

Using these principles will assist defense 

counsel to mitigate the amount of a plaintiff’s 

compensatory damages. 

Dealing with the collateral source rule as 

it applies to future—as opposed to past— 

damages, however, is more complicated. 

While defense counsel can make a strong 

argument that the collateral source rule 

should not apply to the medication that a 

plaintiff received free of charge up to the 

date of a trial, the argument’s strength 

may diminish regarding future free medication. 

For example, a tortfeasor probably 

could not establish how long the gratuitous 

arrangement would last, even if the laws of 

evidence permitted it. Moreover, although 

a product’s cost may decrease over time, a 

tortfeasor would have difficulty establishing 

this point. It seems less likely, therefore, 

that a motion in limine to exclude 

evidence of the reasonable cost of the medication 

from the date of judgment forward 

would succeed. 

Conclusion 

The collateral source rule, although an 

established common law principle, continues 

to evolve. Policy considerations, such 

as double recovery by plaintiffs and the 

potential for undue punishment of defendants, 

support arguments against applying 

the collateral source rule in a number of 

contexts. Moreover, certain circumstances 

present additional justification for these 

policy- based arguments, including scenarios 

in which a plaintiff receives gratuitous 

payments or services—particularly when 

the independent source of the payment or 

benefit probably would not seek subrogation. 

In light of these policy considerations, 

and depending on the law of the particular 

state, skillful defense attorneys should be 

able to argue against the collateral source 

rule’s application in such situations. 

For The Defense ■ November 2012 ■ 45 

Over 20 years of 

Providing experts who 

Truly are 

“EXPERTS” 

Automotive 

Biomechanics 

Chemistry 

Commercial Vehicles 

Construction 

Electrical 

Environmental 

Fire Protection 

Geohydrology 

Geology 

Geotechnical 

Industrial Hygiene 

Injury Causation 

Marine 

Materials 

Mechanical 

Metallurgy 

Roofing 

Structural 

Toxic Torts 

Welding 

Visit our website to see if 

we have the expert you 

need. 

www.forcon.com 

or call 

800-390-0980


Conscious Pain 

and Suffering 

By John F. Parker 

and Greg D. Wyles 

Carbon Monoxide 

Poisoning and 

Survival Damages 

The science involved 

in these scenarios 

should yield multiple 

opportunities for 

limiting damage 

awards throughout the 

litigation process. 

Imagine a chilly fall evening. At the end of a long dark 

road is a humble house where a mother and father are putting 

their kids to bed before retiring for the night. The 

home is quiet except for the low murmur of a gas- powered 

generator coming from the basement. The 

father activated the generator to maintain 

the heat in the house after a blackout darkened 

the neighborhood. However, the father 

failed to open some windows to vent 

the generator’s emissions, and as the family 

drifts off to sleep the house slowly fills with 

a potentially lethal gas. The next morning, 

no one wakes up. We can never determine 

whether the father made a mistake or was 

simply unaware that the generator required 

him to have opened a window. These are the 

harrowing circumstances that frequently 

lead to carbon monoxide poisoning cases. 

A lawsuit will eventually follow, each 

party will assemble its teams of experts, 

and the parties will litigate the liability 

issues. The specific facts of each case dictate 

whether or not a jury will decide the 

outcome; however, the types of damages 

available in such cases remain universal 

throughout them all. In this article, we will 

examine one specific category of damages 

in these claims—those awardable for conscious 

pain and suffering. 

Survival Actions 

Alongside wrongful death damages, many 

states allow representatives to pursue “survival 

actions” for claims that their decedents 

could have pursued if they were still 

alive. See David Leebron, Final Moments: 

Damages for Pain and Suffering Prior to 

Death, 64 N.Y.U.L. Rev. 256, 261 (May 

1989). Such damages can amount to a great 

deal when individuals have suffered a violent 

or a protracted period of pain and suffering 

or both before their deaths. See, e.g., 

Barrett v. Mulligan, 2010 Ky. App. Unpub. 

Lexis 310 (Ken. Ct. App. Apr. 9, 2010) 

(affirming a $3,000,000 jury award for 

pain and suffering damages when a decedent 

sustained severe burns and excruciating 

pain in his car for 60 minutes before 

arriving at the hospital and being treated 

for three days before he died). 


■ John F. Parker is a partner and Greg D. Wyles is an associate in the New York City office of Mound Cotton 

Wollan & Greengrass. Mr. Parker’s area of litigation includes the defense of manufacturers for products 

liability claims, toxic tort and long-term exposure defense related to chemical exposures, including lead 

paint poisoning, mold, asbestos, benzene, and beryllium. Additionally, Mr. Parker has extensive experience 

in defending contractors against labor law and construction defect claims. Mr. Wyles has experience in matters 

related to first-party insurance defense and general breach of contract litigation.

Conscious Pain and Suffering 

Putting aside “preimpact terror” damages 

that the laws of some states provide, courts 

generally will deny conscious pain and suffering 

damages when a decedent has perished 

instantaneously or was unconscious 

throughout an entire ordeal. See Phiri v. 

Joseph, 32 A.D.3d 922, 923, 822 N.Y.S.2d 

573 (N.Y. App. Div. 2006) (granting a summary 

judgment denying conscious pain 

and suffering damages because evidence 

showed that decedent perished instantaneously); 

Collins v. Jamaica Hosp., 195 

A.D.2d 534, 534, 600 N.Y.S.2d 729 (N.Y. 

App. Div. 1993) (granting a summary judgment 

denying pain and suffering damages 

because defendants introduced sufficient 

evidence to show that decedent was anesthetized 

from time of injury up until her 

death). While this article will not cover 

“preimpact terror” damages, some states 

will award these damages when a decedent 

sees the instrument of his or her 

death thereby becoming severely frightened. 

Compare Cochrane v. Schneider Nat’l 

Carriers, Inc., 968 F. Supp. 613, 615 (D. 

Kan. 1997) (indicating that Kansas does 

not allow damages for preimpact fright), 

and Byrd v. Wal-Mart Transport. LLC, 2009 

U.S. Dist. Lexis 99692, at *16 (S.D. Ga. Oct. 

23, 2009) (disallowing damages for preimpact 

fright; however, writing in dicta, 

“Georgia law requires some evidence that 

the decedents actually anticipated the collision 

before a recovery… is allowed”) (citations 

omitted). 

Conscious pain and suffering damages 

become more complicated, however, when 

someone does not die instantly but experiences 

unconsciousness, semiconsciousness, 

or both during the relevant time 

period before death. This happens very 

often with carbon monoxide poisoning. 

See, e.g., Facciponte v. Briggs & Stratton 

Corp., 2011 U.S. Dist. Lexis 96646 (M.D. 

Pa. Aug. 29, 2011). 

Carbon monoxide poisoning produces 

what is frequently described as flu-like 

symptoms manifesting in headache and 

vomiting before death. See Turner v. Wilson 

Line of Mass., 242 F.2d 414, 419 (1st 

Cir. 1957). In fact, the evidence in fatal carbon 

monoxide poisoning cases often shows 

that the exposures took place overnight and 

that the decedents seemed to be asleep during 

the relevant time periods. See, e.g., Facciponte, 

2011 U.S. Dist. Lexis 96646 (M.D. 

Pa. Aug. 29, 2011). Such scenarios appear 

ripe for partial summary judgment successes 

on the conscious pain and suffering 

portions of damages. But cases involving 

fatal instances of carbon monoxide poisoning 

are distinct from cases that deal with 

pain and suffering when individuals live 

through these ordeals only to experience 

ongoing health problems, or from cases 

involving fatal carbon monoxide poisoning 

accompanied by exposure to fire. See, 

e.g., DuBose v. Bhakta (Dallam Co. Tex., 

June 17, 2004) (apportioning $305,000 of 

a jury verdict award for pain and suffering 

caused by near fatal carbon monoxide 

exposure resulting in long-term injury); 

McCord- Shell v. Volkswagen of Am., Inc., 

736 F. Supp. 172, 174 (N.D. Il. 1990) (differentiating 

between levels of pain and suffering 

associated with burning to death versus 

being asphyxiated by the carbon monoxide 

caused by the flames). 

Motions for Partial 

Summary Judgments 

While a plaintiff bears the burden of proving 

conscious pain and suffering during 

the trial stage, for a defendant to succeed 

with a motion for a summary judgment 

dismissing such damages, the defendant 

must conversely show the absence of such 

proof. See Phiri, 32 A.D.3d at 923 (granting 

a summary judgment in favor of the 

defendants on the pain and suffering claim 

in a car accident case because the plaintiff 

failed to introduce a question of fact on the 

decedent’s consciousness after the accident 

or preimpact terror beforehand); Haque v. 

Daddazio, 84 A.D.3d 940, 941, 922 N.Y.S.2d 

548 (N.Y. App. Div. 2011) (reinstating a 

summary judgment granted in favor of the 

defendants on the pain and suffering claim 

because the plaintiff did not introduce 

a question of fact on the decedent’s post 

accident consciousness in a car accident 

case); Collins, 195 A.D.2d at 534 (reversing 

a denial of the defendants’ motion for 

a summary judgment on pain and suffering 

damages in a medical malpractice case 

because the defendants introduced sufficient 

evidence to show that the decedent 

was anesthetized the entire time until her 

death). Therefore, the challenges of proof 

that defendants face in their motions for 

summary judgments foreshadow those 

that plaintiffs eventually will face during 

trials. 

Furthermore, while evidence of conscious 

pain and suffering can be relatively 

straightforward in car accident cases 

such as Haque and Phiri, it can be trickier 

when it comes to carbon monoxiderelated 

deaths. Because carbon monoxide 

is a “silent killer” and intoxicant (1) eyewitnesses 

are seldom available to testify about 

the consciousness of decedents during the 

exposure periods, and (2) carbon monoxide 

poisoning can coexist with and precipitate 

a sleep state. 

In fact, very few judicial opinions have 

assessed the merits of a motion for a summary 

judgment on pain and suffering damages 

when someone has died in his or her 

sleep from carbon monoxide poisoning. 

See Boushele v. Anderson’s Heating and 

Air Cond., Inc., 1999 Mont. Dist. Lexis 347, 

at *11 (Missoula Co. Mont. Feb. 17, 1999) 

(“Defendants… contend that the claim for 

pain and suffering cannot survive, as the 

deceased died in his sleep, and no evidence 

has been shown that he experienced conscious 

pain and suffering. Plaintiff counters 

that existence of therapeutic levels of 

pain reliever in the decedent’s blood points 

to the possibility of some distress prior to 

death. Plaintiff also notes the position of 

decedent on his bed points to some distress. 

While Plaintiffs’ position is tenuous, 

a question of fact exists nonetheless, and 

summary judgment is hereby denied.”); 

Masters v. Courtesy Ford Co., Inc., 758 So. 

2d 171 (La. Ct. App. 2000) (finding that the 

plaintiff was unable to recover damages 

for pain and suffering as the decedent was 

unconscious because of carbon monoxide 

before the crash resulting in his death), 

vacated on other grounds by, 765 So. 2d 

1056 (La. 2000). But the decisions do not 

include enough on-point analysis to offer 

much guidance about when the courts generally 

view a defendant’s evidence as sufficient 

to support a summary judgment for 

a defendant regarding conscious pain and 

suffering damages in a fatal carbon monoxide 

case. 

Motions to Exclude 

Evidence from Trials 

Without eyewitnesses and physical evidence 

pertaining to consciousness, plaintiffs 

will often depend on the speculation 



of their experts to show pain and suffering. 

See, e.g., Facciponte, 2011 U.S. Dist. 

Lexis 119293 (M.D. Pa. Oct. 17, 2011); Daniel 

v. Coleman Co. Inc., 2008 WL 696592 

(W.D. Wash. Mar. 11, 2008) (No. 06-cv- 

5706). In response, a defense attorney may 

then move to exclude this testimony under 

the rules of evidence applicable in the relevant 

jurisdiction. Most recently, the U.S. 

Judges mayreview and 

adjust survival damages 

even after a jury has 

awarded them for conscious 

pain and suffering. 

District Court for the Middle District of 

Pennsylvania grappled with this issue in 

Facciponte v. Briggs & Stratton Corp., in 

which the families of four men who died 

of carbon monoxide poisoning caused by 

a portable generator sued its manufacturer 

and distributor for, among other things, 

pain and suffering damages. Facciponte, 

2011 U.S. Dist. Lexis 96646, at *1–2 (M.D. 

Pa. Aug. 29, 2011). Here, the defendants 

moved to exclude certain portions of the 

plaintiffs’ expert’s opinions under Federal 

Rule of Evidence 702 and Daubert v. Merrill 

Dow Pharmaceuticals, Inc., 509 U.S. 

579 (1993), particularly opinion testimony 

about whether the decedents, who were 

found in close proximity to their sleeping 

bags and appear to have perished while 

asleep or resting, experienced pain and suffering 

before they died. Facciponte, 2011 

U.S. Dist. Lexis 96646, at *23–25. 

The court refused to grant the defendants’ 

motion to exclude the plaintiffs’ 

expert’s testimony and explained the ruling 

as follows: 

Defendants do not dispute that Dr. 

Penney, a toxicologist with decades of 

experience in researching the effects 

of carbon monoxide on animals and 

humans, with hundreds of publications 

and presentations to scientific audience 

on the subject, is qualified by experience 

and training to render an opinion 


in the area of the effects of carbon monoxide 

on the decedents in this case. The 

court agrees that Dr. Penney is qualified 

on these matters. Defendants urge the 

court to find that Penney’s conclusions 

about the amount of suffering decedents 

experienced, whether they were awake 

during their poisoning, and the time of 

their deaths are insufficiently supported 

by his sources. Defendants’ complaints 

are more with the adequacy of Penney’s 

conclusions than with the sources for 

them. The court finds that Penney’s conclusions, 

based on his examination of the 

scene and investigators’ reports, as well 

as his extensive background and study 

in carbon monoxide poisoning, are sufficiently 

based on facts and data for a jury 

to consider. Defendants may make their 

arguments about the persuasiveness of 

his claims to the jury. The motion will 

be denied on this point. 

Id. at *24–25 (emphasis added). 

On a motion for reconsideration, the 

court granted the defendants’ motion in 

limine to exclude Dr. Penney’s opinion 

that the decedents were awake during their 

carbon monoxide intoxication as it was 

based on lay intuition rather than scientific 

method. Facciponte, 2011 U.S. Dist. Lexis 

119293, at *14–16 (M.D. Pa. Oct. 17, 2011). 

However, the court was not persuaded 

when the defendants argued that the court 

should exclude Dr. Penney’s opinion about 

the decedents’ pain and suffering because 

his scientific hypothesis was not actually 

testable. Facciponte, 2011 U.S. Dist. Lexis 

119293, at *20 (“Dr. Penn[e]y’s methodology—review 

of existing animal studies and 

the record of human victim interviews—is 

a reasonable way to study carbon monoxide 

exposure. The court is unpersuaded by 

defendants’ argument that Dr. Penn[e]y’s 

methodology is unreliable because it has 

not been tested.”). In other words, even 

though the scientific community cannot 

expose human subjects to high levels of 

carbon monoxide to measure resulting 

pain or discomfort, the court preserved the 

jury’s ability to hear this aspect of Dr. Penney’s 

opinion dealing with carbon monoxide 

incapacitation, viewing it as sufficiently 

scientifically reliable because Dr. Penney 

partly based it on reviews of animal studies 

and partly on interviews that he conducted 

personally with humans who had 

experienced but survived carbon monoxide 

poisoning. However, the Facciponte 

jury eventually found that the remaining 

defendant was not liable, so the jury never 

quantified any potential pain and suffering 

damages. The claim against another 

second defendant—the distributor of the 

generator—eventually was dropped; therefore, 

only one defendant remained during 

the final stage of the litigation. 

Contrarily, the U.S. District Court 

for the Western District of Washington 

excluded the same expert’s opinion regarding 

pain and suffering damages in a similar 

case involving two men who were killed 

by carbon monoxide poisoning caused by 

their operation of a propane heater. See 

Daniel v. Coleman, 2008 WL 696592 (W.D. 

Wash. Mar. 11, 2008) (No. 06-cv-5706). A 

third victim in Daniel survived the carbon 

monoxide when his alarm clock awakened 

him before his poisoning became fatal. See 

R. Hanley Dep. Tr. at 32:2-7 (Nov. 9, 2006). 

In assessing the defendants’ motion to 

exclude, Judge Strombom held: 

I do have a concern with regard to Dr. 

Penney’s opinion with regard to this 

consciousness of pain and suffering just 

before death. The specific information 

provided to this court by way of specific 

cites to his deposition show that 

only I think several people survived and 

none of them provided support for Dr. 

Penney’s conclusions. There is a federal 

court judge here in this building whose 

favorite term is “Ipse Dixit,” [in Latin, 

“he himself said it”] when he is dealing 

with Daubert motions, and I believe 

that is the case here with regard to Dr. 

Penney’s conclusion that there was consciousness 

of—conscious paralysis and 

pain and suffering. I don’t think he has 

provided any scientific basis to support 

that conclusion. There is nothing in the 

literature. Peer review, in my view, is 

analysis and review done by someone 

outside your particular group. There has 

nothing been done in that regard. And 

while he might be the most qualified 

toxicologist in order to give that opinion, 

there has to be a basis for it that can 

be recreated and analyzed. And I don’t 

believe that he has presented that basis to 

the court. So I’m going to be excluding his 

testimony with regard to that, consciousness 

of pain and suffering.

Hearing Tr. of Hon. Karen Strombom at 

43:20–44:19 (Mar. 20, 2008) (emphasis 

added). The jury in Daniel eventually found 

in favor of the defendants. See Daniel v. 

Coleman Co. Inc., 599 F.3d 1045, 1047 (9th 

Cir. 2010) (denying the motion for a new 

trial). 

Accordingly, it is difficult to predict how 

different judges will react, even to the identical 

expert’s opinion. However, without 

eyewitness testimony or physical evidence, 

and without the ability to introduce expert 

opinion about alleged conscious pain and 

suffering, it would seem highly onerous for 

a plaintiff to meet the plaintiff’s burden of 

proving these damages during a trial. 

Post-Verdict Remedies 

Judges may review and adjust survival damages 

even after a jury has awarded them for 

conscious pain and suffering. See Leebron, 

supra, at 308. For example, New York courts 

will adjust survival awards through remittitur 

if they find them to be “grossly excessive.” 

See Alfieri v. Cabot Corp., 17 A.D.2d 

455, 235 N.Y.S.2d 753, 760 (N.Y. App. Div. 

1962) (ordering a new trial unless the defendant 

stipulated to reduce a $20,000 pain 

and suffering award to $7,500 for an individual 

who died of carbon monoxide poisoning 

seemingly in his sleep; “[t]here is 

no evidence to sustain the award to plaintiff 

Alfieri for conscious pain and suffering. 

There is no evidence that the deceased 

ever regained consciousness, or experienced 

pain. In fact the testimony offered 

by plaintiff was to the effect that carbon 

monoxide has a ‘stuporing, stupefying effect… 

of not making a person alert’ to the 

danger.”), aff’d, 13 N.Y.2d 1027, 195 N.E.2d 

310, 245 N.Y.S.2d 600 (N.Y. 1963); Caldecott 

v. LILCO, 417 F.2d 994, 996 (2d Cir. 1969) 

(awarding remittitur for conscious pain and 

suffering award). When judges issue remittiturs 

they tend to reduce the conscious pain 

and suffering awards by approximately half. 

See Leebron, supra, at 308. 

Consequently, even if a defendant’s motion 

for a summary judgment fails, and a 

jury ends up awarding damages for pain 

and suffering, a judge may still substantively 

reduce them should he or she find 

them to be grossly disproportionate. Additionally, 

a defense attorney sometimes 

can diminish the likelihood that a jury will 

award pain and suffering damages if the attorney 

can exclude the expert opinion advancing 

the decedent’s pain and suffering 

earlier in the proceedings. Partly because 

the science behind conscious pain and suffering 

in these situations often seems as 

ephemeral and transient as fatal carbon 

monoxide gas itself, this scenario yields 

multiple opportunities for limiting conscious 

pain and suffering damage awards 

throughout the litigation process. 

Product Liability/Evaluation 

Product failures and operator contact with machine parts can lead to catastrophic events 

resulting in human injury and property damage. These events may be the result of errors 

made during a product’s design, manufacture, or assembly. An understanding of product 

development, from inception to delivery, enables our engineers to identify deficiencies in 

these processes and render opinions regarding machine designs, guards, and warnings. 

We have evaluated hundreds of products and honed the skills necessary to pinpoint the 

cause of failures and related defects. 

RELY ON OUR EXPERIENCE. 

RELY ON OUR EXPERTS. 

Visit www.semke.com for more information. 888.804.5020 



A Waivable Defect 

By Sara Deskins 

and Kathryn Isted 

Current Application 

of the Forum 

Defendant Rule 

Until the Supreme 

Court weighs in, defense 

attorneys representing 

forum defendants must 

be mindful of the circuit 

split and pay particular 

attention to the law 

in the jurisdictions in 

which they practice. 

The forum defendant rule prohibits defendants from 

removing to the federal courts when any defendant joined 

to a case is a citizen of the state where the case was filed. 

However, the circuit courts have split on whether a plain- 

tiff waives the right to object to a violation 

of the forum defendant rule if the plaintiff 

does not file a motion for remand within 30 

days after the filing of the removal notice. 

Generally, if a case has been improperly removed 

to a federal court, the federal court 

can remand the case at any time in the proceeding, 

including on appeal, if the court 

lacks subject matter jurisdiction. However, 

if a removal defect relates to the removal 

procedure, then the plaintiff must file the 

motion to remand within 30 days after the 

notice of removal was filed or the plaintiff 

has waived the right to correct the defect. 

The following article discusses whether the 

forum defendant rule is procedural, and 

thus waivable, or jurisdictional, and thus 

nonwaivable, the current state of law in the 

11 circuits, and practical considerations for 

defense counsel addressing this issue. 

The Forum Defendant Rule 

Part (b) of the removal statute, 28 U.S.C. 

§1441, provides for removing cases from 

a state court to a federal court based on 

diversity of citizenship: 

A civil action otherwise removable 

solely on the basis of the jurisdiction 

under section 1332(a) of this title [diversity 

jurisdiction] may not be removed if 

any of the parties in interest properly 

joined and served as defendants is a citizen 

of the State in which such action is 

brought. 

28 U.S.C. §1441(b)(2). 

Courts have interpreted this statutory 

language as imposing a “forum defendant 

rule” on cases removed from a state court 

on the basis of diversity jurisdiction. Herd 

v. Scotty’s Contracting & Stone, L.L.C., 

CIV.A. 09-313-KSF, 2009 WL 4016004, at 

*1 (E.D. Ky. Nov. 19, 2009). The forum defendant 

rule permits a defendant to remove 

a case from a state court based on diversity 

of citizenship “only if none of the parties 

in interest properly joined and served 


■ Sara Deskins and Kathryn Isted are associates in Greenberg Traurig’s Product Liability & Mass Torts and 

Pharmaceutical, Medical Device & Health Care Litigation Groups in Atlanta. Ms. Deskins and Ms. Isted have 

experience representing and defending pharmaceutical and medical device clients in federal and state courts, 

including experience with multidistrict litigation and consolidated state court litigation. Ms. Deskins and Ms. 

Isted also have experience with mass torts, consumer class actions, and medical malpractice claims. In addition, 

Ms. Deskins is an active member of the DRI Young Lawyers Committee Publications Subcommittee.

as defendants is a citizen of the State in 

which such action is brought.” Regions 

Bank v. Am. Justice Sch. of Law, Inc., CIV 

A 5:08CV-134-M, 2009 WL 909548 (W.D. 

Ky. Mar. 30, 2009). The forum defendant 

rule generally prohibits a defendant from 

removing a case to a federal district court 

when the concern that underpins diversity 

jurisdiction—prejudice to one or more 

out-of-state defendants—are not present 

because a plaintiff chose to file the lawsuit 

in the defendant’s own home state courts. 

Ethington v. Gen. Elec. Co., 575 F. Supp. 2d 

855, 858 (N.D. Ohio 2008); NFC Acquisition, 

LLC v. Comerica Bank, 640 F. Supp. 

2d 964, 969 (N.D. Ohio 2009). 

If a removal of a case involves a forum 

state defendant, the case was not properly 

removed based on federal diversity jurisdiction. 

If the removal of the action then 

was a procedural defect, a plaintiff will 

have waived the right to fix the defect by 

not moving to remand the case within 30 

days following removal. 28 U.S.C. §1447(c) 

(providing that a motion to remand based 

on a procedural defect “must be made 

within 30 days after the filing of the notice 

of removal”); Page v. City of Southfield, 45 

F.3d 128, 133 (6th Cir. 1995) (holding that 

“§1447(c) does not authorize sua sponte 

remands for purely procedural defects.”). 

However, if this deficiency is deemed 

jurisdictional, then a court is obligated to 

remand the matter back to the state court. 

Id. (“If at any time before final judgment it 

appears that the district court lacks subject 

matter jurisdiction, the case shall be 

remanded.”); Probus v. Charter Commc’ns, 

LLC, 234 F. App’x 404, 406 (6th Cir. 2007) 

(“[c]ourts must examine subject matter 

jurisdiction ‘on their own initiative’”). 

Whether courts in a circuit generally 

interpret a violation of the forum defendant 

rule as jurisdictional or procedural can significantly 

affect a case and a defense strategy. 

However, the U.S. Supreme Court has 

not decided the issue, and the U.S. circuit 

courts interpret the rule differently. The 

First, Second, Third, Fifth, Seventh, Ninth, 

Tenth, and Eleventh Circuits hold that a 

violation of the forum defendant rule is 

procedural and thus waivable; the Eighth 

Circuit holds that a violation of the forum 

defendant rule is jurisdictional and thus 

not waivable; and the Fourth and Sixth Circuits 

have not decided. 

Applicable Supreme Court Precedent: 

Grubbs v. General Electric Credit Corp. 

Although the U.S. Supreme Court has not 

decided whether a violation of the forum 

defendant rule is jurisdictional or procedural, 

the Grubbs v. General Electric 

Credit Corp., 405 U.S. 699 (1972), decision 

is instructive. Circuit and district 

courts cite Grubbs and use the reasoning 

of Grubbs to support their holdings regarding 

the jurisdictional versus procedural 

interpretation. In Grubbs, General Electric 

Credit Corp. (GECC) filed an action 

in a state court against Grubbs and, subsequently, 

Grubbs filed a “cross- action” 

seeking damages from General Electric 

Co. (GE). Grubbs, 405 U.S. at 700. Later, 

Grubbs filed cross- actions against additional 

parties, one of which was the United 

States, because it claimed that the United 

States and the other parties were its creditors, 

and it sought to have the court determine 

the priority of its debts. Id. at 700–01. 

The United States removed the entire action 

to a U.S. district court under 28 U.S.C. 

§1444, which allows removal of a foreclosure 

action against the United States. Id. at 

701. The U.S. district court tried the case 

without a jury. Id. The court awarded damages 

to Grubbs and held that the other parties 

take nothing by their actions. Id. at 702. 

At no time after the United States removed 

the action did Grubbs object to the U.S. 

district court taking jurisdiction over the 

entire action. Id. at 701. 

GECC appealed to the court of appeals, 

which found that removal of the entire 

action under 28 U.S.C. §1444 was improper 

and, thus, the court of appeals remanded 

the case to the state court. Id. at 702. 

Grubbs appealed the court of appeals’ 

remand to the U.S. Supreme Court. Id. 

The U.S. Supreme Court reversed the court 

of appeals remand order, holding that 

the district U.S. court had subject matter 

jurisdiction through diversity jurisdiction 

regardless of whether the case had 

been improperly removed under 28 U.S.C. 

§1444. Id. at 704. The U.S. Supreme Court 

explained that 

where after removal a case is tried on 

the merits without objection and the 

federal court enters judgment, the issue 

in subsequent proceedings on appeal 

is not whether the case was properly 

removed, but whether the federal district 

court would have had original jurisdiction 

of the case had it been filed in 

that court. Id. 

In other words, as long as subject matter 

jurisdiction exists, defects in the procedural 

mechanism for removing a case to 

a federal district court are waived if the 

case was decided by the district court on 

the merits. 

Whether courts in a circuit 

generally interpret a violation 

of the forum defendant 

rule as jurisdictional or 

procedural can significantly 

affect a case and a 

defense strategy. 

Circuit and district courts following 

Grubbs have used its holding and reasoning 

to support their decisions regarding 

whether the forum defendant rule is 

jurisdictional, and violating it results in 

a nonwaivable defect, or procedural, and 

violating it results in a waivable defect. 

For example, the Third Circuit found that 

the U.S. Supreme Court in Grubbs “clearly 

suggested, even if it did not directly hold, 

that it does not view the removal statute 

as imposing independent jurisdictional 

restrictions on the federal courts.” Korea 

Exchange Bank v. Trackwise Sales Corp., 

66 F.3d 46, 50 (3d Cir. 1995). Likewise, the 

Ninth Circuit relies on Grubbs to distinguish 

between elements of removal procedure, 

which can be waived, and restrictions 

on a U.S. district court’s subject matter 

jurisdiction, which cannot be waived. 

See Lively v. Oats Markets, Inc., 456 F.3d 

933, 942 (9th Cir. 2006). The U.S. District 

Court, Central District of California interpreted 

Grubbs as allowing a federal court to 

remand a case at any time on the basis of a 

removal statute violation “unless the matter 

has proceeded to judgment on the merits, 

and the federal court would have had 

subject matter jurisdiction had the case 



been filed in federal court.” WRS Motion 

Picture and Video Lab. v. Post Modern Edit, 

Inc., 33 F. Supp. 2d 876, 876 (C.D. Cal. 1999). 

Thus, the U.S. District Court, Central District 

of California determined the forum 

defendant rule to be jurisdictional consistent 

with Grubbs. Id. at 878. 


The Majority Interpret Violating 

the Rule as Procedural Error 

Creating a Waivable Defect 

The majority of circuit courts, including 

the First, Second, Third, Fifth, Seventh, 

Ninth, Tenth, and Elevenths Circuits, hold 

that a violation of the forum defendant 

rule is procedural and, thus, waivable. See 

Farm Constr. Servs., Inc. v. Fudge, 831 F.2d 

18, 22 (1st Cir. 1987) (holding that a violation 

of the forum defendant rule did not 

strip the district court of its jurisdiction 

because it was a “technical” defect that had 

been waived); Woddward v. D.H. Overmyer 

Co., 428 F.2d 880, 882–83 (2d Cir. 1970); 

Blackburn v. United Parcel Serv., Inc., 179 

F.3d 81, 90 n.3 (3d Cir. 1999) (describing 

a §1441(b) violation as a waivable removal 

defect); Korea Exchange Bank v. Trackwise 

Sales Corp., 66 F.3d 46, 50 (3d Cir. 1995); 

In re Shell Oil Co., 932 F.2d 1518, 1523 (5th 

Cir. 1991); Hurley v. Motor Coach Indus. 

Inc., 222 F.3d 377, 380 (7th Cir. 2000) (holding 

that the forum defendant rule “is more 

a matter of removal procedure, and hence 

waivable, than a matter of jurisdiction”); 

Lively v. Wild Oats Markets, Inc., 456 F.3d 

933, 940 (9th Cir. 2006) (describing removal 

by a forum defendant as a “technical” violation); 

Am. Oil Co. v. McMullin, 433 F.2d 

1091, 1095 (10th Cir. 1970) (describing a 

§1441(b) violation as a waivable defect in 

removal proceedings); Pacheco de Perez v. 

AT & T Co., 139 F.3d 1368, 1372 n.4 (11th 

Cir. 1998); Borg- Warner Leasing v. Doyle 

Elec. Co., 733 F.2d 833, 835 n.2 (11th Cir. 

1984). Although these circuits agree in 

interpreting the forum defendant rule as 

raising procedural issues, their procedural 

postures and rationales differ. 

For example, the First Circuit in Fudge 

relied on the plaintiff’s actions to determine 

“implicit consent” to federal jurisdiction. 

See Fudge, 831 F.2d at 22. In Fudge, 

the defendants removed the case to a federal 

court on the basis of diversity jurisdiction, 

and the federal district court rendered 

a final judgment dismissing the plaintiff’s 

complaint. See id. at 19. The removal 

was improper under the removal statute 

because the defendant was a citizen of the 

state where the action was filed. Id. at 22. 

The plaintiff appealed, arguing that the federal 

district court did not have jurisdiction 

to enter a judgment against it because “the 

parties acted upon a mutual mistake of law 

with respect to the propriety of removal to 

federal court.” Id. at 21. The First Circuit 

upheld the federal district court’s judgment, 

explaining that the plaintiff’s “prosecution 

of the case in federal court for 

approximately one year, and its failure 

to object to removal until after judgment 

had been rendered, constitute[d] implicit 

consent to federal court jurisdiction and 

waiver of its right to object to removal.” 

Id. at 22. 

The Third Circuit in Korea Exchange 

Bank, however, found that whether the case 

could have been filed initially in a federal 

court would determine the outcome. See 

Korea Exchange Bank v. Trackwise Sales 

Corp., 66 F.3d at 47. In Korea Exchange 

Bank, the plaintiff, a citizen of New York, 

filed a complaint in a New Jersey state court 

against three defendants, all citizens of 

New Jersey. See id. at 47. The first defendant 

that the plaintiff served, Trackwise Sales 

Corp., timely removed the action to a federal 

district court on diversity jurisdiction 

grounds. Id. Nothing happened in the case 

for over seven months after the federal district 

court sua sponte remanded the case 

due to violation of the forum defendant 

rule. Id. The defendants appealed the federal 

district court’s remand order. Id. The 

Third Circuit reversed, holding that “an 

irregularity in removal of a case to federal 

court is to be considered ‘jurisdictional’ 

only if the case could not initially have been 

filed in federal court.” Id. at 50 (emphasis 

added). The Third Circuit recognized in the 

holding that unlike in Grubbs, the federal 

district court in the Korea Exchange Bank 

case had not entered a final judgment. Id. 

Similar to Korea Exchange Bank, the 

Fifth Circuit in In re Shell Oil Co. based its 

holding on the language of the removal 

statute and the statute’s underlying policy. 

See In re Shell Oil Co., 932 F.2d at 1521–22. 

In In re Shell Oil Co., the plaintiffs moved 

for a remand 34 days after the filing of the 

defendants’ notice of removal, arguing that 

two of the defendants were citizens of the 

forum state. Id. at 1518. The federal district 

court granted the remand, and the 

defendants appealed. Id. The Fifth Circuit 

reversed the remand order, holding that 

“improper removal under §1441(b) is [] a 

waivable removal defect.” Id. at 1522. To 

support the holding the court relied on the 

text of 28 U.S.C. §1447(c), which states that 

“‘a motion to remand the case on basis of 

any defect in removal procedure must be 

made within 30 days after the filing of the 

notice of removal.’” Id. at 1521 (quoting 28 

U.S.C. §1447(c)). The court explained that 

the “policy behind the rule is to prevent a 

party who is aware of a defect in removal 

procedure from using the defect as insurance 

against later unfavorable developments 

in federal court.” Id. at 1522. 

The Minority Interpret Violating 

the Rule as a Jurisdictional Issue 

Creating a Nonwaivable Defect 

The Eighth Circuit Court of Appeals is the 

only circuit court to hold expressly that 

failing to comply with the forum defendant 

rule is a jurisdictional issue thus creating a 

nonwaivable defect. See Hurt v. Dow Chem. 

Co., 963 F.2d 1142, 1146 (8th Cir. 1992). In 

Hurt, the plaintiff filed the lawsuit in a state 

court against the defendants for personal 

injuries allegedly resulting from exposure 

to pesticide manufactured and applied by 

the defendants. Id. at 1143. The defendants 

filed a petition to remove the case to the 

federal court on the basis of federal question 

removal jurisdiction. Id. The plaintiff 

moved to remand the case to the state 

court, arguing that the case was improperly 

removed on federal question grounds. 

Id. at 1143–44. The federal district court 

denied the plaintiff’s motion, holding that 

removal on federal question grounds was 

proper at the time of removal, and plaintiff 

“waived any non- jurisdictional objection 

to the impropriety of removal.” Id. at 

1144 (quoting Hurt v. Dow Chem. Co., No. 

90-0783-C (3), slip op. 3 (E.D. Mo. May 22, 

1991)). The plaintiff appealed to the Eighth 

Circuit. Id. 

In the appeal, the sole question presented 

was whether removal was proper. 

Id. The defendants argued that removal 

was proper because a preemption defense 

arising under federal law gave the federal 

district court federal question jurisdiction 

and, in the alternative, the federal

district court had original diversity jurisdiction. 

Id. For the purposes of this article, 

only the court’s analysis regarding diversity 

jurisdiction is discussed. The parties 

agreed that when the plaintiff originally 

filed the action in the state court the parties 

were diverse. Id. at 1145. However, the 

defendants removed the case under 28 

U.S.C. §1441, under which a defendant may 

not remove a case to a federal court on the 

basis of diversity jurisdiction if any of the 

defendants is a citizen of the state where 

the action was filed. Id. One of the defendants 

was a resident of the state from which 

the case was removed; thus, the federal district 

court did not have diversity jurisdiction 

when the case was removed. Id. 

The defendants argued that a violation 

of the forum defendant rule was merely 

a procedural defect and that the plaintiff, 

therefore, waived any right to object to 

the removal. Id. The Eighth Circuit examined 

Grubbs and found that it was factually 

distinguishable from the facts in 

Hurt. Id. The Eighth Circuit noted that in 

Grubbs neither party ever questioned the 

removal’s correctness until after the federal 

district decided the merits of the case; 

then the plaintiff appealed to the Fifth Circuit, 

without objecting to the removal in 

the federal district court, and Fifth Circuit 

then sua sponte questioned the federal 

district court’s jurisdiction and ultimately 

remanded the case. Id. at 1145–46. The 

Eighth Circuit found Grubbs inapplicable 

because the plaintiff in Hurt did object to 

the removal to the federal district court in 

that court, and “subjectmatter jurisdiction 

is not a mere procedural irregularity 

capable of being waived.” Id. at 1146. In a 

footnote, the Eighth Circuit reiterated that 

in the Hurt case “there is an absence of 

subjectmatter jurisdiction,” and “[a] jurisdictional 

defect, unlike a procedural defect, 

cannot be waived.” Id. at 1146 n.1. 

While the Eighth Circuit factually distinguished 

Grubbs from Hurt based on the 

Hurt plaintiff’s objection to the removal in 

the federal district court, it did not analyze 

thoroughly or explain why failing to 

comply with the forum defendant rule is a 

subjectmatter jurisdiction defect and not 

a procedural defect. Instead, the Eighth 

Circuit merely concluded that this type 

of violation was a subjectmatter jurisdictional 

defect. 

Undecided Circuits 

Answering whether violating the forum defendant 

rule creates a waivable defect while 

litigating a case in the Fourth or Sixth Circuit 

Courts of Appeal becomes a bit murkier. 

Neither circuit has definitely answered 

the question. District courts in each district 

have provided tentative but not definitive 

guidance. The federal district courts in the 

Fourth Circuit have found that the defect 

created by violating the forum defendant 

rule is procedural and waivable. See, e.g., 

Rehbein v. Biomet Orthopedics, LLC, Civil 

No. WDQ-12-1247, 2012 WL 2340000 (D. 

Md. June 15, 2012). On the other hand, 

federal district courts in the Sixth Circuit 

have found that violating the forum defendant 

rule creates a jurisdictional and 

nonwaivable defect. See, e.g., Regions Bank 

v. Am. Justice School of Law, No. 5:08CV- 

134-M, 2009 WL 909548 (W.D. Ky. March 

30, 2009). 

The Fourth Circuit District 

Courts—Procedural Defect 

The Fourth Circuit has not addressed 

whether violating the forum defendant 

rule results in a procedural or a jurisdictional 

defect. See Rehbein v. Biomet Orthopedics, 

LLC, Civil No. WDQ-12-1247, 2012 

WL 2340000, at *2 n.11 (D. Md. June 15, 

2012). However, several federal district 

courts in that circuit have weighed in on 

the issue and all have, thus far, concluded 

that violating the rule creates a procedural 

and waivable defect if a plaintiff does not 

raise an objection within 30 days. See, 

e.g., Ada Liss Group v. Sara Lee Branded 

Apparel, No. 1:06CV610, 2007 WL 634083, 

at *3–4 (M.D.N.C. Feb. 26, 2007); Councell 

v. HomerLaughlin China Co., 823 F. Supp. 

2d 370, 379 (N.D. W.Va. 2011); Rehbein, 

2012 WL 2340000, at *2. 

The most thorough analysis of the issue 

in the Fourth Circuit has come from the 

U.S. District Court, Northern District of 

West Virginia in the Councell case. 823 F. 

Supp. 2d 370 (N.D. W.Va. 2011). In Councell, 

the plaintiffs filed a lawsuit in a West 

Virginia state court for wrongful termination. 

Id. at 373. The parties were diverse, 

but the defendant had its principal place 

of business in West Virginia. Id. The defendant 

subsequently removed the case to 

the federal court on the basis of both federal 

question and diversity jurisdiction. 

Id. The plaintiffs filed a motion to remand, 

arguing that neither federal question nor 

diversity jurisdiction existed. Id. The plaintiffs 

specifically argued that diversity jurisdiction 

did not exist in the case because the 

defendant had its principal place of business 

in West Virginia, so the forum defendant 

rule precluded the lawsuit. Id. The 

defendant argued that the plaintiffs had 

The court explained 

that the “policy behind the 

rule is to prevent a party 

who is aware of a defect 

in removal procedure 

from using the defect as 

insurance against later 

unfavorable developments 

in federal court.” 

waived the forum defendant rule argument 

because they failed to file a motion 

to remand within 30 days of removal as 

required by 28 U.S.C. §1447(c). 

The federal district court evaluated 

“whether removal violative of the forum 

defendant rule is a procedural defect or 

amounts to a complete lack of subjectmatter 

jurisdiction.” Id. at 378. In evaluating 

this question, the court found that 

while the Fourth Circuit has not yet ruled 

on the issue, the majority of other federal 

circuit courts to address the issue “have 

found that removal by a forum defendant 

is a procedural defect, and thus waivable.” 

Id. The court also pointed to other district 

courts within the Fourth Circuit that had 

considered the issue and found a violation 

of the forum defendant rule to be procedural. 

Id. (citing Ada Liss Grp., 2007 WL 

634083, at *3–4). In addition, the court 

found the rationale set forth by the Ninth 

Circuit in Lively v. Wild Oats Markets, Inc., 

456 F.3d 933 (9th Cir. 2006), persuasive. 

Id. Specifically, the court agreed with the 



If a forum defendant 

is considering removal to 

a federal district court in 

the Eighth Circuit based 

on diversity jurisdiction, 

counsel should advise the 

client against removal. 

Lively court that “if diversity jurisdiction 

exists and a defendant removes a case in 

violation of the forum defendant rule, neither 

party will be prejudiced if the case 

were to remain there, and the plaintiff may 

still exercise control over the case by moving 

for remand.” Id. at 379 (citing Lively, 

456 F.3d at 940). 

The court distinguished Hurt, reasoning 

that “[w]hile this Court agrees with the 

Eighth Circuit that all statutory requirements 

of jurisdiction must be met for 

jurisdiction to exist… it cannot agree that 

§1441(b) is one of those requirements.” Id. 

(distinguishing Hurt, 963 F.2d 1142 (8th 

Cir. 1992)). The court concluded that “failure 

to comply with the forum defendant 

rule is a procedural defect and the ability 

to remand based upon violation of §1441 is 

waivable under §1447(c).” Id. The court also 

stressed that if a plaintiff objects to removal 

based on a violation of the forum defendant 

rule, a plain reading of §1447(c) requires 

the plaintiff to file a motion to remand 

within 30 days. Id. at 380. It is not enough 

for the plaintiff to merely put defendant on 

notice that it objects to the removal; it must 

actually file a motion to remand. Id. Failing 

to file a motion to remand within 30 days 

waives any objection that a plaintiff may 

have to removal by a forum defendant. Id. 

The Sixth Circuit District Courts— 

Jurisdictional Defect with an Exception 

The most recent district court decisions in 

the Sixth Circuit analyzing whether a violation 

of the forum defendant rule is procedural 

or jurisdictional determined that 


the rule is jurisdictional, but they recognize 

an exception under Grubbs that would 

allow a court to retain jurisdiction when 

a case has proceeded to finality or near 

finality without objection by either party 

to the improper removal. Wooten v. Greenview 

Hosp., Inc., No. 1:10-CV-00034-TBR, 

2010 WL 1742539, at *4 (W.D. Ky. April 28, 

2010); see also Capital One Bank (USA), NA 

v. Ponte, No. 11-11072, 2011 WL 2433480, at 

*3 n.2 (E.D. Mich. May 26, 2011) (“Although 

there is also some lack of clarity surrounding 

whether a court may sua sponte raise 

the “forum defendant rule” as jurisdictional, 

on these facts, this Court concludes 

that it may do so.”). But see GE Comm’l Distrib. 

Finance Corp. v. W.W. Cycles, Inc., No. 

4:10CV2673, 2011 WL 1831752, at *3 (N.D. 

Ohio May 12, 2011) (“[t]he forum defendant 

provision is a procedural removal requirement 

that is waived if it is not raised by a 

timely motion to remand”). 

The most thorough analysis of this issue 

was conducted in 2009 by the U.S. District 

Courts, Western District of Kentucky and 

Western District of Michigan. See Regions 

Bank v. Am. Justice School of Law, No. 

5:08CV-134-M, 2009 WL 909548 (W.D. 

Ky. March 30, 2009); Balzer v. Bay Winds 

Fed. Credit Union, 622 F. Supp. 2d 628, 630 

(W.D. Mich. 2009). In Regions Bank, the 

plaintiff filed the lawsuit in a Kentucky 

state court. The defendants removed the 

action to the U.S. District Court, Western 

District of Kentucky on the basis of diversity 

jurisdiction. Various defendants were 

citizens of Kentucky, the forum state. Thus, 

the action was improperly removed. Id. at 

*1. However, the plaintiff raised no objection 

to the removal. The U.S. District Court, 

Western District of Kentucky evaluated 

whether the forum defendant rule is procedural 

and waivable or jurisdictional and 

nonwaivable. Id. 

The court first found that “[m]any Circuits 

have addressed this issue and most 

have held that the forum defendant rule 

is procedural and is waived if not raised 

by the plaintiff within 30 days following 

removal.” Id. (citing 16 Moore’s Fed. Prac. 

107.14[2][e] n.81). The court also found that 

these circuits have interpreted Sixth Circuit 

precedent as holding that the forum 

defendant rule is procedural. See Lively 

v. Wild Oats Markets, Inc., 456 F.3d 933, 

940 (9th Cir. 2006) (citing Handley- Mack 

Co. v. Godchaux Sugar Co., 2 F.2d 435, 437 

(6th Cir. 1924) (describing removal by a 

forum defendant as a “technical” violation) 

(describing a violation of the forum 

defendant rule as a waivable “procedural 

defect”)); Plastic Moldings Corp. v. Park 

Sherman Co., 606 F.2d 117, fn 1 (6th Cir. 

1979). The Regions Bank court pointed out 

that most circuits finding a violation of the 

rule procedural cited Grubbs for support. 

The court in Regions Bank ultimately 

found the forum defendant rule jurisdictional 

and remanded the case to the 

state court. See also Johnston v. Panther II 

Transp., 2007 WL 2625262 (N.D. Ohio 2007) 

(finding the rule jurisdictional). However, 

the court found that Grubbs provided an exception 

to this rule in certain case- specific 

instances. Specifically, the Regions Bank 

district court found that Grubbs provided 

an exception to the rule that a §1441(b) defect 

is a jurisdictional defect: the defect 

becomes procedural “when a case is improperly 

removed but is tried to judgment 

on the merits without objection, a party 

waives his right to later raise the issue of 

lack of subjectmatter jurisdiction at the 

time of removal.” Regions Bank, 2009 WL 

909548, at *5. The district court went on to 

discuss the policy rationale underlying the 

Grubbs exception, finding that it “ensures 

that substantial judicial resources already 

expended in reaching a judgment will not 

be needlessly wasted if the case could have 

been brought in federal court in the first instance.” 

Fed. Nat’l Mortgage Ass’n v. LeCrone, 

868 F.2d 190, 194 (6th Cir. 1989). See 

also Thompson v. Karr, 182 F.3d 918, 1999 

WL 51297, at *3–4 (6th Cir. 1999). 

The Regions Bank federal district court 

expressed its frustration with the lack of 

clarity from the Sixth Circuit on this issue: 

If the Court does not remand this matter, 

there is no assurance that an appellate 

panel which raises the question of 

jurisdiction will apply the Grubbs exception. 

And if they do not, a great deal of 

time, effort and money will be wasted…. 

For the Court’s part, it would welcome 

an appeal. This is a question that needs 

resolution. 

Regions Bank, 2009 WL 909548, at *6. 

Subsequently, the U.S. District Court, 

Western District of Michigan also found 

the rule jurisdictional, but after conducting 

a similar analysis to Regions Bank, it com-

plained that “this Court does not believe 

the Sixth Circuit has issued a definitive and 

binding ruling on point….” Balzer v. Bay 

Winds Fed. Credit Union, 622 F. Supp. 2d 

628, 630 (W.D. Mich. 2009). Balzer found 

that the analysis required “calls for a more 

nuanced consideration of both the nature 

of the procedural flaws, and the context of 

the case at the time the flaw is identified. 

This approach permits a court to balance 

the respective interests of judicial economy, 

finality of judgments, and the seriousness 

of the procedural flaw.” Id. at 631. 

Practical Considerations 

for Defense Counsel 

Attorneys representing clients that are 

forum defendants that have or plan to 

remove cases on the basis of diversity jurisdiction 

may find the following tips helpful 

to consider. 

First, know the law in the particular 

jurisdiction. As mentioned, the circuit 

courts disagree on whether removal by a 

forum defendant is a procedural or jurisdictional 

defect. Defense counsel need to 

be aware of the applicable law in their 

jurisdiction. Defense counsel practicing in 

jurisdictions following the majority rule 

and representing a forum defendant in 

a case removed on the basis of diversity 

jurisdiction should feel confident that as 

long as plaintiff did not file a motion to 

remand within 30 days of the notice of 

removal, the plaintiff has waived his or her 

right to later object. In jurisdictions such 

as the Fourth, Sixth, and Eighth Circuits, 

where the courts are less clear or follow 

the minority rule, defense counsel must 

be wary of removal when they represent 

forum defendants. 

Second, advise clients early. If a client 

has removed a case to a federal district 

court in the Fourth, Sixth, or Eighth Circuits 

based on diversity jurisdiction, advise 

the client as soon as possible of this issue. 

In these jurisdictions, a violation of the 

forum defendant rule may be interpreted 

as a subject matter jurisdiction defect. The 

plaintiff or the court itself may object to the 

subject matter jurisdiction of the court at 

any point. Thus, it is in a defense counsel’s 

best interest to know where the relevant 

issue falls in this circuit split and advise a 

client on the front end of the potential for a 

remand to the state court. 

Advise forum defendant clients with 

cases in the Eighth Circuit against removal 

based on diversity jurisdiction. If a forum 

defendant is considering removal to a federal 

district court in the Eighth Circuit 

based on diversity jurisdiction, counsel 

should advise the client against removal. 

Even if the plaintiff never objects to the 

removal, the court could, at any point, raise 

the issue on its own and remand the case 

for lack of subject matter jurisdiction. If the 

state court is extremely unfavorable to the 

defendant, consider evaluating the possibility 

of removal with the client for the purpose 

of appealing the issue eventually to 

the U.S. Supreme Court in the hopes that 

the Court would resolve the circuit split the 

client’s favor. 

Conclusion 

The majority of U.S. circuit courts find 

that a violation of the forum defendant 

rule is a procedural defect, and a plaintiff 

will waive objecting rights if the plaintiff 

Engineers, Architects, Scientists & Fire Investigators 

Admiralty / Maritime 

Architecture / Premises Safety 

Automotive Engineering 

Aviation 

Biomechanical Engineering 

Construction Claims / Injuries 

Dram Shop / Liquor Liability 

Education / Supervision 

Electrical Engineering 

Environmental / Toxic Torts 

does not properly object to the removal in 

a motion to remand within 30 days of the 

filing of the notice of removal. However, the 

U.S. Supreme Court has yet to weigh in on 

this issue, and at least one circuit court has 

found the defect to be jurisdictional and 

not subject to waiver. 

Defense attorneys representing forum 

defendants must be mindful of the circuit 

split and pay particular attention to the law 

in the jurisdictions in which they practice. 

Attorneys practicing in the Eighth Circuit 

need to advise their forum clients as early 

as possible of this issue, and they may want 

to advise against removal based on diversity 

jurisdiction unless a client is willing 

and able to litigate the case perhaps all 

the way to appealing to the U.S. Supreme 

Court. Attorneys practicing in the Fourth 

and Sixth Circuits will also want to advise 

their clients of the circuit split and unsettled 

authority in their jurisdiction as early 

as possible in a case. 

Fire / Explosion 

Human Factors 

HVAC / Plumbing 

Occupational Health / Safety 

Oil & Gas Drilling 


Sports and Recreation 

Structural Engineering 

Toxicology 

Vehicle Collisions 

With 175 experts at one firm, Robson Forensic provides expertise in more 

than 75 unique disciplines. Visit us online for expert bios and CVs. 

www.robsonforensic.com | 800.813.6736 



Warnings and 

Instructions 

By Kenneth Ross 

Answers to 

Some of My 

Favorite FAQs 

While the responsibility 

of providing adequate 

warnings and instructions 

should not be taken 

lightly, having competent 

legal and technical 

personnel available 

to answer difficult 

questions should alleviate 

manufacturers’ fears. 

■ Kenneth Ross is a former partner and now Of Counsel in the Minneapolis 

office of Bowman and Brooke LLP, where he practices in product safety, 

regulatory compliance and liability prevention. He served previously as an 

in-house attorney at Westinghouse Electric and Emerson Electric and has 

advised on issues involving warnings and instructions for over 30 years. 


Providing advice on warnings and instructions has occupied 

a good portion of the last 35 years of my professional 

life. First as an in-house lawyer and then as outside counsel, 

I have tried to provide both legal and practical advice 

in this area. Given the lack of law on many 

issues involving warnings and instructions, 

it is impossible simply to offer a legal 

opinion and have it provide useful guidance 

for a manufacturer. 

Therefore, those who advise on these 

subjects must be prepared to use their 

legal knowledge and combine it with practical 

judgment to provide a realistic set of 

options for a manufacturer to use to make 

decisions. 

DRI has just published a global compendium 

on the duty to warn, which discusses 

the law in all 50 states and the 

District of Columbia as well as in a number 

of foreign countries. This will be useful 

in understanding the law in these various 

areas, especially when you litigate a case 

in a particular jurisdiction. But it won’t 

be that helpful in making decisions about 

warnings and instructions that will be sold 

throughout the United States and internationally. 

Focusing on a particular jurisdiction 

is not useful when you wish to comply 

with the law in all regions in which a product 

will be sold. 

The intent of this article is not to discuss 

in detail the legal analysis that might 

apply to answering certain questions, but 

to provide short practical answers to questions 

that I and others have received and 

answered over the years. To the extent that 

someone has written on the subject previously, 

I will provide a link to the more 

comprehensive article. I will assume that 

a reader understands generally the duty 

to warn and is familiar with the applicable 

American National Standards Institute 

(ANSI) standards. 

FAQs 

Are there guidelines that detail the 

process of developing warnings 

ANSI issued a standard dealing with onproduct 

warnings in 1991 (ANSI Z535.4) 

and how to incorporate safety information 

into collateral instructions in 2006 (ANSI 

Z535.6). These standards contain guidelines 

on how to develop, write and format warnings 

and instructions. In addition, there are 

productspecific laws and standards that 

governments, ANSI and other standards 

organizations have issued over the years 

that pertain to warnings such as the Federal 

Hazardous Substances Act, enforced by

the U.S. Consumer Product Safety Commission, 

for chemicals in consumer products 

and ANSI Z400.1/Z129.1-2010 for industrial 

chemicals and material safety data sheets. 

These productspecific laws and standards 

would take precedence and, therefore, need 

to be identified and considered. The ANSI 

Z535.4 standard states: 

There are a number of existing American 

National Standards that are recognized 

for particular industries or 

specific uses. Compliance with such a 

standard may be considered for the particular 

industry or use. It is not the 

intent of this ANSI Z535.4 standard to 

replace existing standards or regulations 

that are uniquely applicable to a specific 

industry or use. 

In addition to ANSI and other U.S. organizations 

issuing standards, the International 

Organization for Standardization 

(ISO) has issued standards on warnings 

and instructions for all products (ISO 3864) 

and also for specific product categories 

such as ISO 11684 for agricultural equipment, 

and the European Union has issued 

directives on products such as machinery 

that contain warnings requirements. 

Also, there are various productspecific 

guides that have been created by government 

agencies for particular product categories. 

For example, the U.S. Consumer 

Product Safety Commission published 

“Manufacturer’s Guide to Developing Consumer 

Product Instructions,” in October 

2003; the British Department of Trade 

and Industry published an excellent booklet 

called “Writing Safety Instructions for 

Consumer Products” in November 1998; 

in 1993, the U.S. Food and Drug Administration 

(FDA) published “Write it Right: 

Recommendations for Developing User 

Instruction Manuals for Medical Devices 

in Home Health Care,” which incorporates 

ANSI Z535 concepts; and the European 

Union issued a “Guide to Application of 

the Machinery Directive” in June of 2010. 

Lastly, if a product has a third-party certification, 

such as Underwriter’s Laboratory 

(UL) or the Canadian Standards Association 

(CSA), the manufacturer’s labels 

and instructions need to comply with the 

requirements of that standard. 

For some products, there may be multiple 

laws, regulations, standards and guides 

that need to be considered when developing 

warnings and instructions. That is one 

reason why personnel involved in developing 

such information need to be familiar 

with all of the applicable reference documents 

that need to be considered. Products 

do need to comply with some documents, 

and some might just provide helpful guidance. 

The goal is to use all of the relevant 

resources available and be prepared to 

defend the adequacy of your process and 

your warnings. 

For a good overview, see J.P. Frantz, T.P. 

Rhoades & M.R. Lehto, “Practical Considerations 

Regarding the Design and Evaluation 

of Product Warnings,” in Warnings 

and Risk Communication 291–311 (M.S. 

Wogalter, D.M. DeJoy, & K.R. Laughery 

eds., Taylor & Francis 1999). In addition, 

see Shaver & Braun, Is Your Company Using 

a Process to Develop Warning Information, 

In-House Defense Quarterly, Summer 2007, 

and Ross & Adams, Legally Adequate 

Warning Labels: A Conundrum for Every 

Manufacturer, For The Defense, Oct. 1998. 

Is there a risk in exceeding the voluntary 

standards for product labeling applicable 

to my product Is that an admission 

that my product is more dangerous than 

my competitors, or does this create a 

problem for my competitors by providing 

warnings that are better than theirs 

The law is clear that mere compliance with 

standards is not an absolute defense in 

product liability cases. Therefore, you must 

meet or exceed the standards. All warnings 

can be used to support an argument that a 

product is hazardous and allow a plaintiff 

to argue that you should have designed the 

product to eliminate a hazard rather than 

warned purchasers about it. So excessive 

warnings can create some problems for 

you, especially if you warn about risks that 

are very remote or have low severity. This 

can also create problems for your competitors 

in that you have created a “better” 

warning that will be compared to your 

competitor’s warnings. 

It is better for an industry to adopt what 

everyone thinks are adequate labels as the 

standard. Then, each manufacturer will 

comply with the standard and not feel 

compelled to do better. With that said, if 

an industry does a poor job in developing 

a standard or does not have a warnings 

standard, you should put labels on your 

product and provide instructions that you 

believe are appropriate for safety and necessary 

to comply with the law. In addition, 

hopefully these also could comply with 

ANSI Z535. 

What if there are product-specific 

laws such as the Federal Hazardous 

Substances Act (FHSA) or standards 

such as UL’s that conflict with 

ANSI Z535.4 Is it imperative that 

you also follow ANSI Z535 

There is no evidence that the ANSI Z535.4 

formats are superior to other formats or 

requirements. It is important to identify 

and to try to comply with the more productspecific 

requirements first. But, remember 

that the plaintiff can argue that you should 

have exceeded the product specific standards 

and, many times, that would be the 

Z535.4 standard. Therefore, if you can also 

comply with the Z535.4 standard, so much 

the better. 

Is there a problem if you select 

the wrong signal word 

Z535.4 uses three signal words for injury 

related hazards: DANGER, WARNING and 

CAUTION. In the Annex to the standard, 

there is a detailed process for selecting the 

correct signal word. Many manufacturers 

have been concerned about what could 

happen if they select the wrong signal 

word, given the definitions in the standard. 

The signal word is an attention getter and 

also transmits part of the message concerning 

probability and severity of harm. However, 

the word message and the pictorial in 

the label are more important in communicating 

the message. 

So while it is preferable for a signal 

word and a message panel to be consistent, 

meaning, for instance, that you want 

to pair DANGER with “will cause serious 

injury or death,” I think that it is unlikely 

that a jury would find a warning label 

defective if the signal word was wrong. 

As long as the word message and the pictorial 

accurately describe the hazard and 

the probability and the severity, the signal 

word becomes less important. 

With that said, once you determine the 

potential severity of harm as being a risk of 

serious injury or death, the signal word is 

usually going to be WARNING. You would 

save DANGER for risks involving a high 



probability (“will”) of harm and, according 

to the standard, this signal word should be 

limited to the “most extreme situations.” 

Do you always need to state the 

hazard, consequences and avoidance 

procedures even if they are obvious 

The ANSI Z535.4 standard in Annex B 

reads: 

For some products, 

there may be multiple laws, 

regulations, standards and 

guides that need to be 

considered when developing 

warnings and instructions. 


The word message on a hazard alerting 

sign typically communicates information 

to a viewer on the type of hazard, 

the consequence of not avoiding the hazard, 

and how to avoid the hazard. Many 

factors must be considered when determining 

whether to omit consequence, 

avoidance, or type of hazard information 

in the word message. Factors to consider 

include whether the message can 

be inferred from a symbol, other text 

messages, user training, or the context 

in which the safety sign is used. 

Certainly, it is clear that many hazards 

and avoidance procedures can be readily 

inferred when a label is on a product and 

near the hazard. Studies also support this 

view. It has been said that “[f]rom a practical 

standpoint, this study affirms ANSI 

Z535.4’s acknowledgment that people can 

infer a variety of information about hazards 

in the context of product use without 

reading explicit statements on a label.” J.P. 

Frantz, T.P. Rhoades, R.J. Shah, S.M. Hall, 

J.J. Isaacson & C.G Burhans, ANSI Z535 

signal words and the ability to infer hazard 

and consequence information—1992 versus 

2004 in Proceedings of the Human Factors 

and Ergonomics Society (HFES) 49th 

Annual Meeting 1790–94. (HFES 2005). 

But you need to be careful about deleting 

some of these statements just to save 

a little space. If you think that a message 

is “obvious” from viewing a product, you 

could test that assumption by asking a 

small focus group or even just a few people 

at your company. 

For example, you might delete the avoidance 

procedure when a product becomes 

extremely hot during operation and you 

say that there is a burn hazard. To avoid the 

burn, you don’t touch the product when it is 

operating. That is pretty obvious. The problem 

is that the product may stay hot for a 

while after it is turned off and that will not 

be obvious, particularly for a bystander 

who didn’t even know that the product had 

been in operation. 

In addition, you might not warn about 

a particular hazard because it is obvious. 

For example, you might not warn about a 

crush hazard in a conveyor belt. However, 

the severity and the probability also have 

to be obvious before I would omit a hazard 

warning. Taking the crush hazard in a conveyor 

belt example, it may not be obvious 

that a user’s hand can be cut off or crushed, 

and the user might just think that his or her 

hand could be pinched. 

When can you use pictorials instead of 

text on labels and in the manual And 

if you do, can you rely on pictorials 

without human factors testing 

I have written extensively on this subject. 

See The Duty to Warn Illiterate and 

Non- English- Reading Product Users, In- 

House Defense Quarterly, Winter 2008, 

and Warnings and Instructions: Updated 

U.S. Standards and Global Requirements, 

DRI Product Liability Committee Newsletter, 

Fall 2011. Even though this is a complex 

subject that is not readily susceptible to a 

short answer, I will attempt to provide one. 

There are some pictorials that can readily 

be used in labels in the United States in 

place of certain text. Most of them show 

the hazard and the consequences and have 

been used for decades. Some of them show 

the avoidance procedure. One example is 

the circle and slash. While many of these 

pictorials are very understandable, the general 

view among most lawyers, including 

me, is that, with some exceptions, it is 

risky to use no-text labels with only pictorials 

in the United States. Some messages 

are difficult, if not impossible, to transmit 

with pictorials alone, and a label with 

many pictorials really needs to be studied 

for a while for a reader possibly to understand 

the entire message. That defeats the 

purpose of a label, which should be understandable 

at a glance. 

One way to use pictorials in lieu of text 

is to do human factors testing as described 

in ANSI Z535.3. However, such testing is 

expensive, and the results may still be challenged 

by a plaintiff who says that he or she 

didn’t understand the pictorial. 

The use of no-text labels outside the 

United States is much more prevalent and 

certainly less of a legal risk. However, a company 

should consider the likelihood that 

products shipped outside the United States 

with no-text labels could end up being sold 

to consumers in the United States. 

Should label and/or manual be tested 

for usability and comprehension 

Testing is done very infrequently and in 

only very specific circumstances. Most of 

the time, a word message is clearly understandable 

to foreseeable users and does 

not need to be tested for comprehension. 

If new pictorials are created or a pictorial 

is used for a young child or someone with 

similar comprehension ability, some testing 

may be appropriate. When testing is 

undertaken for the pictorial, it usually just 

tests comprehension and not compliance. 

In addition, when we test a pictorial, we can 

also test the words to confirm that they are 

understandable. 

For more information on testing, see 

J.P. Frantz, T.P. Rhoades & M.R. Lehto, 

“Practical Considerations Regarding the 

Design and Evaluation of Product Warnings,” 

supra, at 305–06, and Ross, Warnings 

and Instructions: Updated U.S. Standards 

and Global Requirements, supra. 

Should labels and manuals in 

the United States be bilingual 

(English and Spanish) 

Again, this is a very complex issue, and I 

have written about it extensively. See The 

Duty to Warn Illiterate and Non- English- 

Reading Product Users, supra, and Multilingual 

Warnings and Instructions: An 

Update, DRI Product Liability Committee 

Newsletter, Fall 2012. 

However, the quick answer is that the 

law does not generally require any lan-

guage other than English. Despite that, 

some retailers do demand at least Spanish 

on warnings and instructions sold in their 

stores. Unless there is a customer request, 

a manufacturer should preferably add more 

pictorials rather than add a foreign language 

to try to communicate with non- 

English- reading product users. Once you 

add a foreign language, you have to decide 

which one to add, and then you need to be 

sure that the instruction manual is also in 

that language. And sometimes Spanish is 

not the only language that needs to be considered. 

Lastly, adding other languages will 

sometimes diminish the conspicuity of the 

English message and thereby increase the 

potential liability for English- reading users 

who have a hard time finding the English 

portion of the message. 

When can safety messages be in the 

manual and not in the label When 

on the label and not in the manual 

There is very little guidance in the law or 

the general warnings standards on these 

questions. Some productspecific standards, 

including UL requirements, do specifically 

say whether the warning must be on a product 

or in the manual. Without that requirement, 

it is up to a manufacturer to decide. 

My operating principle is based on an 

analysis of whether the reader needs to 

see the information each time that he or 

she uses a product, or whether he or she 

can read the manual and then refer to that 

information later on as needed. Steve Hall 

from Applied Safety and Ergonomics and 

chair of the ANSI Z535.4 subcommittee 

said on this question: 

There is no hard and fast rule, but generally 

you want to try to provide messages 

in a way that gives people a reasonable 

chance to read them at an appropriate 

time. So, for tasks that are expected 

to involve referring to the manual (e.g., 

assembly, troubleshooting, maintenance, 

etc.), it is generally reasonable to 

provide safety messages in the relevant 

part of the manual, and not on a label. 

Conversely, for scenarios where the target 

audience is not reasonably expected 

to have access to a manual, a label may 

be more appropriate. 

In addition, Professor David Owen 

addressed this issue in his product liability 

hornbook: 

Whether adequacy requires in any given 

case that warnings be placed directly 

on the product involves a balance of the 

significance of the hazard, the user’s 

need for the information, the availability 

of a feasible means to place the warnings 

on the product, and other factors 

in the calculus of risk. If feasible, reason 

normally suggests that important 

warnings be placed on the product itself 

rather than in a pamphlet, booklet, or 

information sheet that can be damaged, 

lost, destroyed or stuffed in an office 

drawer.… Depending on the circumstances, 

however, a warning may still 

be adequate even if it is provided off the 

product in a manual or other writing. 

Product Liability Law 601 (2d ed. Thomson 

West 2008). 

For a more extensive discussion, see my 

article Location of Warnings: On Product 

or in the Manual, DRI Product Liability 

Committee Newsletter, Summer 2008. Also 

see J.P. Frantz, T.P. Rhoades, & M.R. Lehto, 

“Practical Considerations Regarding the 

Design and Evaluation of Product Warnings,” 

supra, at 303. 

What about warnings and instructions 

on component parts that an original 

product manufacturer (OEM) 

inserts into its final product 

An OEM is responsible for providing adequate 

warnings and instructions for its 

finished product, including all of its components. 

Therefore, any inadequacies could 

result in liability for the OEM. However, 

the component part supplier can also be 

responsible for inadequacies in the warnings 

and instructions provided with its 

component. 

The OEM should try to buy components 

from suppliers that appear to have adequate 

warnings and instructions. Therefore, if a 

component has warnings, for example, that 

do not comply with ANSI Z535.4 or any of 

the other standards, then the OEM should 

ask the supplier to upgrade the labels. If 



the OEM assumes the duty to revise component 

part labels, it could also become liable 

for any inadequacies in the warnings. 

The burden should really be on the supplier 

to provide adequate information and 

not the OEM. 

In the component part purchasing process, 

an OEM should provide requirements 

and guidelines to the component supplier 

The useof no-text labels 

outside the United States is 

much more prevalent and 

certainly less of a legal risk. 

about how the OEM wants the warnings and 

the instructions to appear and be provided. 

The OEM will then need to decide if it will 

provide the component supplier’s instructions 

as a separate manual or incorporate 

them into the final product manual. If they 

are incorporated into the manual, and the 

OEM makes changes, the supplier should 

approve the final version of the OEM’s manual. 

And the supplier should indemnify the 

OEM in case there are inadequacies in the 

supplier’s warnings and instructions. 

Let’s change the facts and say that the 

component part supplier doesn’t know 

how its component will be used, where it 

will be placed and where the operator will 

be standing in relation to its component. 

How can the component part supplier provide 

warnings and instructions that will 

be adequate for all uses and locations Well 

it can’t, and it shouldn’t be required to do 

so. But the supplier should have some idea 

of the various ways in which its product 

can be used and should attempt to provide 

some guidance to the OEM on safety information 

that needs to be incorporated into 

the instructions depending on the various 

uses that the supplier can anticipate. 

The supplier might also provide to the 

OEM loose warning labels with instructions 

on where to place them, depending 

on how the component is incorporated into 

the final product and where the hazard will 

be located for the user. Putting the burden 

on the OEM to make the final decision on 


the warnings and instructions is appropriate 

in this situation. Whether you can get 

an OEM to take that responsibility depends 

on the sophistication of the OEM. If an 

OEM doesn’t know what it is doing, then 

maybe the component supplier should visit 

the OEM’s plant and “approve” the installation 

of the component and placement of 

the warnings. 

Do you always need to provide a hard 

copy of the instruction manual, or can 

you put the manual on a CD and include 

it with the product or have a reference 

(website link or QR code) on the label to 

the manual on the company’s website 

The standards don’t discuss whether a hard 

copy instruction manual is required, or 

whether the information can be provided 

in another way. The reason is probably that 

most manufacturers provide their instructions 

in a hard copy. However, there have 

been manufacturers of certain products 

that have recently asked about not providing 

a hard copy. Instead they want to include 

the instructions as an electronic file 

in a product or in a CD format or just provide 

on a label a link to the manual on a 

website. Examples of such products would 

be cell phones, computers, TVs and certain 

machinery or equipment run by computers. 

I have seen no law that discusses this 

issue and since, except as discussed below, 

virtually no laws or standards say one way 

or another, a manufacturer could omit the 

hard copy and argue that what it provided 

was adequate under the circumstances. 

The ANSI Z535.6 subcommittee has 

been discussing the increased use of social 

media and company websites and how that 

relates to the required instructions. I anticipate 

that the committee will add some 

sections on this subject in the 2016 ANSI 

Z535.6 revision. However, for now, the 

ANSI Z535.6 standard does mention “supplemental 

directives,” which could include 

references to website links, QR codes and 

other recognized types of safety messages. 

In Europe, the Guide to the EU Machinery 

Directive specifically requires that 

a hard copy of the manual accompany 

machinery. Until the Guide changes, manufacturers 

of machinery have no other 

choice. However, in March 2012, the European 

Commission approved the use of electronic 

forms of instructions with certain 

medical devices intended for use exclusively 

by medical professionals. 

Manufacturers of active implantable 

medical devices, implantable medical 

devices, fixed installed medical devices 

and medical devices fitted with visual display 

systems will be able to provide in electronic 

form use instructions previously 

provided on paper. 

Manufacturers providing electronic instructions 

will be required to include notices 

on product packaging on how to access 

the electronic forms of instruction, or provide 

supplementary printed instructions 

on how to access electronic instructions. 

Even before the ANSI committee includes 

provisions on electronic instructions, manufacturers 

should consider using new technology 

to transmit safety information more 

effectively and efficiently. The ability to provide 

animations, videos, expanded illustrations 

and other more interesting ways to 

explain how to safely use products should 

be considered and utilized when possible. 

There is even technology being developed 

to allow attaching verbal warning labels to 

a product. Vesstech Inc., http://www.vesstech. 

com/ (last visited Oct. 1, 2012). 

At a minimum, the onproduct warnings 

should tell a user to read the manual 

before using a product and tell the user how 

to obtain a replacement manual if one is 

missing. This can be done by providing an 

800 number to call, an email address of a 

company employee, or a website link from 

which the user could download a replacement 

manual. 

How do you incorporate safety 

information into the company website 

There are several excellent examples of 

comprehensive websites that discuss product 

safety. See Safety.cat.com, Caterpillar, 

http://safety.cat.com/ (last visited Oct. 1, 2012), 

and Safety Resources, Toro, http://www.toro. 

com/en-us/safety/pages/default.aspx (last visited 

Oct. 1, 2012). They go well beyond just including 

links to manuals. They incorporate 

videos, interactive manuals and safety tips. 

The ANSI Z535.6 subcommittee will be 

considering future revisions, which could 

discuss how to incorporate safety information 

into websites. At the moment, there are 

no requirements to have extensive safety 

information similar to the Caterpillar and 

Toro websites mentioned above. However,

to the extent that there is a growth in such 

websites, the “state of the art” in safety 

websites will be raised and other manufacturers 

may be inclined to provide much 

more information than they currently do. 

When should new or improved 

warnings and instructions be offered 

to prior customers When do you 

need to tell the government 

New and improved warnings and instructions 

might be considered safety improvements, 

or they might be considered an 

admission that the earlier warnings and instructions 

were defective. The common law 

is clear that manufacturers are not required 

to offer safety improvements to prior customers 

if the earlier product was not defective. 

The problem is how do you decide 

whether the earlier product might be considered 

defective and the new safety information 

used as evidence to support the 

claim It is a difficult decision and one that 

is fraught with potential problems, no matter 

what you do. 

Certainly, if the earlier warnings and 

instructions are compliant with the standards 

and the law and the new versions are 

just updated and made a little better, then 

it is arguable that these are just improvements. 

However, if the earlier warnings and 

instructions did not comply with the standards 

or law and were very bad, or if there 

have been a number of lawsuits alleging a 

failure to warn or several jury verdicts ruling 

the warnings defective, then the new 

warnings and instructions might be more 

than just safety improvements. 

This is an important analysis where 

competent defense counsel can also provide 

valuable assistance in addition to your 

safety counsel. Since you don’t know where 

any future case will be brought, it is hard to 

know which state’s law to consider. The best 

approach is to consult with counsel who 

you trust and who is familiar with your 

products and your litigation. 

Then the question is, in the case of consumer 

products, do you need to inform 

the U.S. Consumer Product Safety Commission, 

Health Canada or the Australian 

authorities about the new warnings and 

instructions The reporting laws are different 

from country to country, and you 

need to consider whether the issuance of 

new warnings and instructions to prior 

customers could arguably be considered a 

“recall” and create a reporting responsibility 

to any of these agencies. For more information 

on the reporting requirements, see 

Ross, New Safety Laws May Result in Significant 

New Liability, In-House Defense 

Quarterly, Fall 2011. 

If customers are not properly using 

or maintaining a product and not 

following the label or manual, should 

you send out a reminder to customers 

about the necessity to follow the 

instructions and precautions 

In this question, we assume that the earlier 

warnings and instructions are adequate. 

They just aren’t being followed. This is 

always foreseeable. But that doesn’t create 

a post-sale duty. However, once we become 

aware of this fact and accidents or near 

misses have occurred as a result, a postsale 

duty could arise in some states. See 

Ross and Soule, Post-sale Duties: A Minefield 

for Manufacturers, In-House Defense 

Quarterly, Fall 2006. 

If accidents have occurred and there is 

some way to get the reminder to your customers, 

it is probably a good idea to do it. If 

you can’t find your customers easily, then 

maybe placing a reminder on your website 

is appropriate. 

Of course, a manufacturer may decide 

to redesign future products so that there is 

less of a hazard when users do not follow 

the warnings. In that case, they then have 

another difficult decision: whether to retrofit 

old products with the new designs, such 

as a new safety guard, if that is possible. 

Your instructions warn users not to 

service a product or to perform certain 

repairs. But you know that users are 

going to do it anyway. What do you do 

When you tell users not to do something but 

you know that they will do it anyway, and 

there are safe and unsafe ways to do it, then 

you might be inclined to tell them how to do 

it safely. But then aren’t you “authorizing” 

them to do the service or repair that you 

don’t really want them to do On balance, 

as long as it is reasonably foreseeable that 

they will do the servicing and repairs and 

there are hazards in them doing so, then I 

would continue to encourage them strongly 

not to do it, but then add some basic instructions 

on how to do it correctly and safely. 

One way to handle this is to state that 

the repair or the service instructions are for 

professional service personnel and not for 

the consumer even though the instructions 

are contained in the manual that accompanied 

a product. 

Conclusion 

There are many other questions that I have 

The law does not 

generally require any 

language other than English. 

Despite that, some retailers 

do demand at least Spanish 

on warnings and instructions 

sold in their stores. 

been asked over the years and to which I 

have had to supply answers. There is very 

little law on these important but narrow 

issues. And most of them are not answered 

by any of the standards. Despite that, a 

manufacturer must consider them and 

make a decision. 

While designing a safe product is not 

an easy task, providing adequate warnings 

and instructions is a tough job. It is so easy 

to add words, make a label bigger, provide 

more illustrations in a manual and do other 

things that some jury might believe would 

have prevented an accident. 

While manufacturers shouldn’t be paralyzed 

by the fear of not providing adequate 

warnings and instructions, they should not 

take this responsibility lightly. They should 

use competent legal and technical personnel 

to help, especially on the difficult kinds 

of questions represented above. 

In addition to providing information that 

hopefully will reduce the risk of harm, better 

warnings and instructions might also 

help make a product more marketable in 

that it will be perceived by customers to be 

easier to assemble, use and maintain. And 

they will certainly be easier for defense 

counsel to defend if an incident occurs. 



The CDC Opens 

Pandora’s Box 

By Paul S. Danner 

and William D. Wilson 

Federal Policy 

Change Could 

Unleash Lead Paint 

Poisoning Litigation 

A discussion of the 

previous CDC guidance 

and its critical role in 

litigation, the possible 

motivations for deciding 

to use a reference value to 

define what constitutes 

an elevated blood lead 

level in children, and the 

serious concerns that 

defendants and their 

insurers now face in 

defending these cases. 

On May 16, 2012, the Centers for Disease Control and Prevention 

(CDC) officially decided to eliminate the use of 

the term “level of concern” and instead adopt a “reference 

value” to identify children with “elevated” blood lead levels 

(BLLs). This change is expected to cause a 

seismic shift in lead paint litigation. The 

previous guidance from the CDC identified 

a BLL of 15 micrograms per deciliter 

(μg/dL) as requiring medical intervention. 

The CDC referred to this as the “action 

level.” It also identified 10 μg/dL as the CDC 

“level of concern.” The level of concern figure 

became a de facto threshold for proving 

lead poisoning in certain jurisdictions. 

The new CDC methodology eliminates the 

distinction between the action level and 

the level of concern. The CDC now determines 

what constitutes an elevated lead 

level based on the results of the National 

Health and Nutrition Examination Survey 

(NHANES), which tracks, among other 

things, lead levels in survey participants. 

The new “reference value” is based on the 

lead levels of children ages one to five who 

have BLLs in the top 2.5 percent of children 

tested. This figure currently stands at 5 μg/ 

dL, which is one-half of the former CDC 

level of concern. 

Childhood mean BLLs have dropped 

dramatically over the years and, in turn, 

the number of lead exposure cases has 

decreased. This is due, in large part, to the 

preventative measures that have been put 

into place over the past few decades such 

as eliminating lead in paint and gasoline. 

Although lead exposure has decreased significantly, 

the new CDC position instantly 

increased the population of children with 

“elevated” BLLs by 600 percent from 

approximately 77,000 to almost 450,000. 

In the process, the CDC most assuredly 

reenergized the plaintiffs’ bar to find these 

new potential litigants and to initiate lawsuits. 

This article discusses the previous 

CDC guidance and its critical role in lead 

paint litigation, the possible motivations 

for deciding to use a reference value to 

define what constitutes an elevated blood 

lead level in children, and the serious concerns 

that defendants and their insurance 

companies now face in defending lead 

paint cases. 


■ Paul S. Danner and William S. Wilson are partners in the law firm of Mound Cotton Wollan and Greengrass. 

From the firm’s New Jersey office, they primarily defend insurance and reinsurance companies and 

other commercial clients in matters involving insurance coverage disputes, contract disputes, and product 

liability, construction liability, employer liability, premises liability, and general tort claims. They have extensive 

experience defending toxic tort cases, including exposure to chemicals, mold, asbestos and lead.

Lead—A Historical Perspective 

Lead is a toxin, yet it is ubiquitous. Ctrs. for 

Disease Control and Prevention, Preventing 

Lead Poisoning in Young Children (1985). 

It can be found in the air, soil, and drinking 

water. Lead’s most publicized—or sensationalized—source 

remains lead-based 

paint, which is often found in homes and 

apartment buildings constructed before 

the 1960s. Lead was formerly also a component 

of gasoline. The environmental saturation 

of lead has been reduced over the 

years, primarily by eliminating leaded gasoline 

and removing lead-based paint for 

consumer purchase, although it remains 

ever present. Thus, it is likely that most, 

if not all, people have some lead in their 

bodies. 

Lead exposure in young children has 

driven a cottage industry of personal injury 

litigation for the better part of the past half 

century. The plaintiffs’ bar has historically 

relied on the CDC guidelines, including 

the levels of intervention and concern that 

they identify, to substantiate these claims. 

There is no dispute that when the amount 

of lead in the body reaches certain levels it 

can in some, but not all, cases cause adverse 

health effects. Battle lines form between 

the plaintiffs’ bar on one side and home 

owners, their insurers, and the defense 

bar on the other with each side disputing 

when a BLL becomes legally actionable 

and whether a particular child with a 

particular BLL actually sustained injuries. 

As discussed more below, the recent CDC 

decision about acceptable BLLs has likely 

reshaped that legal landscape. 

The 1975–1991 CDC Statements on 

Preventing Lead Poisoning in Children 

The CDC historically has provided a 

“standard of care” for health-care providers 

to guide them in evaluating children for 

the risk of lead exposure, diagnosing children 

with elevated BLLs, and treating the 

condition. In 1975, the CDC issued a formal 

statement on the screening, diagnosis, 

treatment, and follow- up care of children 

with increased lead absorption or lead poisoning. 

Ctrs. for Disease Control and Prevention, 

Increased Lead Absorption and 


It defined “lead poisoning” as a blood lead 

level equal to or greater than 80 μg/dL 

whole blood. “Undue or increased lead 

absorption” was defined as a BLL in excess 

of 30 μg/dL. The CDC recommended specific 

treatment plans for children based on 

their BLLs. The CDC also recommended 

that all children aged one to five years 

who lived in or frequently visited housing 

units constructed before the 1960s should 

be screened for elevated BLLs at least once 

per year. 

Notwithstanding the 1975 CDC statement, 

BLLs in young children remained 

high by today’s standards for many years. 

A 1970–1976 study of 178,533 children in 

New York City revealed that the geometric 

mean BLL ranged from 20 μg/dL to 30 μg/ 

dL depending on the race of the child. Billick, 

Relation of Pediatric Blood Lead Levels 

to Lead in Gasoline (1980). Thus, legislation 

took effect in 1975 mandating phasing 

out the sale of leaded gasoline over 

the next 10 years. Similar legislation was 

passed by 1978 reducing lead in paint. The 

CDC updated the lead poisoning screening, 

diagnosis, treatment, and follow- up 

care guidance in 1978 and reiterated that a 

BLL of 30 μg/dL was “elevated” for children 

aged one to six years. Ctrs. for Disease Control 

and Prevention, Preventing Lead Poisoning 

in Young Children (1978). 

The phaseout of leaded gasoline and 

lead-based paint had a profound effect 

on BLLs. Data confirmed that the overall 

mean BLL in the population dropped from 

14.6 μg/dL to 9.2 μg/dL in the late 1970s. 

Annest, Trend in the Blood-Lead Levels of 

the U.S. Population: The Second National 

Health and Nutrition Examination Survey 

1976–1980 (1983). So the focus shifted 

from eliminating new sources of lead to 

removing old sources such as existing leadbased 

paint in residential units. In 1982, 

for example, the New York City Council 

adopted Local Law 1, which obligated 

owners of multi- unit dwellings to remove 

or cover paint and other surfaces that contained 

more than 0.7 milligrams of lead per 

square centimeter or 0.5 percent of metallic 

lead. See N.Y. Admin. Code §27-2012(h)(1). 

The CDC recognized by 1985 that “[p]rogress 

ha[d] been made.” Yet, it reduced the 

federal definition of an “elevated” BLL 

from 30 μg/dL to 25 μg/dL. Ctrs. for Disease 

Control and Prevention, Preventing 


The CDC revised the guidance on lead 

poisoning screening, diagnosis, treatment, 

The CDCintends to readjust 

the “reference value” every 

four years based on “the 

most recent populationbased-blood-lead 

surveys 

conducted among children.” 

and follow- up care once again in 1991 and 

reduced the level of intervention to 15 μg/ 

dL. Ctrs. for Disease Control and Prevention, 

Preventing Lead Poisoning in Young 

Children (1991). It also adopted a “level of 

concern” of 10 μg/dL. BLLs of less than 10 

μg/dL were “not indicative of lead poisoning,” 

although the CDC noted that “[s]ome 

adverse health effects have been documented 

at BLLs at least as low as 10 μg/ 

dL.” BLLs ranging from 10 μg/dL to 14 μg/ 

dL were classified as “in the border zone,” 

while children with BLLs of greater than 

15 μg/dL were further categorized based 

on the associated risks. Health-care providers 

received specific instructions on 

how they should care for and treat children 

based on their BLLs. This 1991 CDC 

guidance to health-care providers became 

the “standard of care” for childhood lead 

screening, diagnosis, and treatment for the 

next 20 years. 

The Plaintiffs’ Bar Pushes to 

Redefine “Lead Poisoning” 

The New York Times reported in July 2008 

that lead cases in New York City had fallen 

more than 90 percent since 1995. Sewell 

Chan, Lead Poisoning Cases Decline, N.Y. 

Times, July 8, 2008. In New Jersey, no more 

than 2.7 percent of children tested in 2004 

had a BLL greater than 10 μg/dL. Childhood 

Lead Poisoning in New Jersey—Annual Report 

Fiscal Year 2004. Studies also showed 

that almost 97 percent of those children residing 

in a “high-risk” lead environment 

did not have an elevated BLL. Jones, Trends 

in Blood Lead Levels and Blood Lead Testing 

among US Children Aged 1 to 5 Years, 

1988–2004 (2007). In short, the risk of lead 



exposure had decreased, and so the number 

of children with elevated BLLs dropped. 

Because this pool of potential plaintiffs was 

shrinking, the plaintiffs’ bar turned its attention 

to pursuing lead-based personal 

injury claims on behalf of children with 

BLLs of less than 10 μg/dL. The results were 

mixed. For example, in New York, which 

defines “lead poisoning” as 10 μg/dL, 24 

The burdenthrust on 

health-care practitioners 

to reexamine their patient 

files to comply with 

these new guidelines 

will be significant. 

R.C.N.Y. §11.03, such claims were rejected 

in Arce v. New York City Housing Auth., 265 

A.D.2d 281 (N.Y. App. Div. 1999), and Santiago 

v. New York City Bd. of Health, 8 A.D.3d 

179 (N.Y. App. Div. 2004). Other New York 

courts permitted these claims to proceed. 

See Singer v. Morris Avenue Equities, 895 

N.Y.S.2d 629 (Sup. Ct. Bronx County 2010); 

Rhys v. Rossi, 2009 Slip Op. 32056 (Sup. Ct. 

Queens County 2009); Peri v. City of New 

York, 8 Misc. 3d 369 (Sup. Ct. Bronx County 

2005); Cunningham v. Spitz, 218 A.D.2d 639 

(N.Y. App. Div. 1995). 

In 2005, the CDC Advisory Committee 

on Childhood Lead Poisoning Prevention 

(ACCLPP) officially requested that the CDC 

reduce the level of concern to below 10 μg/ 

dL. Ctrs. for Disease Control and Prevention, 

Preventing Lead Poisoning in Young 

Children (2005). The CDC did not do so. 

Instead, the CDC merely acknowledged 

that the 10 μg/dL level of concern had 

been misconstrued as a “definitive toxicologic 

threshold.” The CDC also expressed 

many concerns with the studies submitted 

by the Advisory Committee on Childhood 

Lead Poisoning Prevention, which 

supposedly demonstrated that lead levels 

below 10 μg/dL had an adverse effect on 

the health of children. Thus, although the 

CDC noted there was “evidence of adverse 


health effects in children with BLL below 

10 μg/dL,” it could not reach a “definitive 

conclusion about causation.” Ctrs. for Disease 

Control and Prevention, Appendix, 

A Review of Evidence of Adverse Health 

Effects Associated with Blood Lead Levels 

< 10 μg/dL in Children (2005). 

The CDC Abruptly Decides to Change 

Position on BLLs After 20 Years 

In January 2012, the Advisory Committee 

on Childhood Lead Poisoning Prevention 

submitted another report to the CDC asking 

that it reevaluate its guidance. Advisory 

Comm. on Childhood Lead Poisoning Prevention, 

Ctrs. for Disease Control and Prevention, 

Low Level Lead Exposure Harms 

Children: A Renewed Call for Primary Prevention 

(2012). In particular, the advisory 

committee called for eliminating using the 

term “level of concern” and requested that 

the CDC use a “reference value” to evaluate 

whether a BLL was in fact “elevated” or 

“not elevated.” The “reference value” would 

measure a child’s BLL against the population 

average or mean value established by 

the National Health and Nutrition Examination 

Survey data rather than using 10 μg/ 

dL. The advisory committee purported to 

eliminate the notion that some threshold 

existed when a child would begin to experience 

the negative health effects of lead 

exposure. In total, the advisory committee 

made 13 recommendations, including 

shifting away from testing and treating to 

preventing lead exposure. 

The May 16, 2012, CDC “response” 

stated that it intended to adopt all of the 

advisory committee’s recommendations, 

subject to available funding. Ctrs. for Disease 

Control and Prevention, Response to 

Advisory Committee on Childhood Lead 

Poisoning Prevention Recommendations 

in “Low Level Lead Exposure Harms Children: 

A Renewed Call for Primary Prevention” 

(May 16, 2012). Most notably, the CDC 

stated that “[s]ince no safe blood lead level 

in children has been identified, a blood 

lead ‘level of concern’ cannot be used to 

define individuals in need of intervention.” 

Consequently, it indicated that it would 

discontinue using the term “level of concern.” 

The CDC agreed that it would use 

a “reference value” based on the 97.5 percentile 

of the population BLL for children 

aged one to five years who were tested for 

lead. This currently is 5 μg/dL. The CDC 

intends to readjust the “reference value” 

every four years based on “the most recent 

population-based-blood-lead surveys conducted 

among children.” 

At first blush, the recent announcement 

by the CDC appears well intentioned. A 

child’s exposure to any toxin should be 

eliminated to the extent possible. Yet the 

benefits of a public health initiative must 

be balanced against its cost and, some 

may say, more importantly, its efficacy. 

Lead poisoning is nowhere near the public 

health concern that it was in the 1970s. 

We haven’t identified any evidence that 

children recently have experienced a spike 

in elevated BLLs that would prompt the 

CDC to act, and the CDC did not mention 

any either when it announced the decision. 

Thus, the timing of the CDC decision 

to rewrite this guidance after 20 years of 

silence raises questions. 

Earlier this year, the U.S. Congress 

slashed funding for the CDC lead- poisoning 

prevention program from $29 million to $2 

million. It has been reported that the CDC 

intends to reduce the Lead Prevention Program 

work force by 20 people. Elizabeth 

Weise & Allison Young, Lead Poisoning 

Guidelines Revised; More Kids Labeled at 

Risk for Lead Poisoning, USA Today, May 

16, 2012. Indeed, the CDC highlighted the 

reduced funding in the May 16 response 

to the recommendations by the Advisory 

Committee on Childhood Lead Poisoning 

Prevention by consistently stating that “full 

implementation” of many of its planned 

initiatives were “contingent on funding.” 

Perhaps it is a mere coincidence that the 

CDC decided suddenly to increase the 

number of children deemed to be “at risk” 

to almost 450,000 on the heels of dramatic 

budget cuts. Yet it is not unreasonable to 

question whether the CDC decision is, at 

least in part, an attempt to lessen the cutbacks 

or even to increase its funding. 

The Impact of the CDC Decision 

The CDC 1991 statement on lead poisoning 

screening, diagnosis, treatment, and follow- 

up care instantly identified a greater 

pool of children as having been exposed to 

potentially “dangerous” levels of lead. The 

plaintiffs’ bar consistently cites this CDC 

guidance as evidence of injury to a child. 

Not surprisingly, lead paint litigation in

New York City exploded in the mid-1990s. 

It would be unrealistic to expect that the 

May 16, 2012, CDC decision would not have 

a similar effect in the years to come. The 

plaintiffs’ bar already had pursued cases 

with BLLs of less than 10 μg/dL before May 

16, 2012. Now, armed with the new CDC 

guidance, property owners and their insurers 

should be forewarned that an onslaught 

of new claims could be on the horizon. 

The defense bar also should prepare 

to handle the sensationalism that surely 

will follow. The most prominent plaintiffs’ 

expert in childhood lead-paint exposure 

cases, Dr. John Rosen, chair of the 

CDC Advisory Committee on Childhood 

Lead Poisoning Prevention when the CDC 

issued the 1985 and 1991 guidance statements, 

by his own admission has received 

hundreds of thousands of dollars acting 

as a plaintiff’s expert since 1991. After the 

CDC recently acted, several news articles 

quoted Dr. Rosen on the “enormous impact 

that a blood lead level of 5 can have forever 

on a child’s life and future academic success.” 

Weise & Young, supra. Christopher 

Portier with the CDC went even further, 

actually stating that the new CDC position 

“will save lives.” Id. These types of grandiose 

statements—whether by paid experts 

or others—are dangerous because they 

misinform the public and can influence 

a potential jury unfairly. Nothing in the 

May 16, 2012, CDC decision indicates that 

BLLs of less than 10 μg/dL have such significant 

adverse health effects, and the science 

hasn’t either. If the scientific proof did indicate 

that BBLs below 10 μg/dL did affect 

people significantly, then most adults who 

grew up in the 1960s and the 1970s with 

BLLs far in excess of 10 μg/dL would have 

neurocognitive issues today. Of course, that 

is simply not the case. 

The CDC has set the new “reference 

value” without having any scientific evidence 

establishing a causal relationship 

between that blood lead level “reference 

value” and adverse health effects. It is based 

solely on those children whose BLLs are in 

the top 2.5 percent of children tested. Perhaps 

ironically, the “reference value” is now 

tied to the success achieved by the Lead 

Prevention Program. As lead levels continue 

to drop, so will the “reference value.” 

In addition, the new CDC “reference 

value” effectively eliminates certainty 

about the time on the risk borne by insurers. 

It seems improbable that the “reference 

value” will stay at its current level 

of 5 μg/dL. In fact, if the historical trend 

to reduce BLLs continues, when the CDC 

readjusts the “reference value,” which the 

CDC will do four years from now, the new 

figure probably will be less than 5 μg/dL. 

Because the statute of limitations does 

not begin to run on a child’s claim until 

the child reaches the age of majority, the 

CDC policy may make any BLL potentially 

actionable level in the future. The CDC has 

opened a Pandora’s box to litigation against 

insurers that insure such risks or that have 

in the past. 

This policy will not just affect property 

owners and their insurers. The burden 

thrust on health-care practitioners to 

reexamine their patient files to comply with 

these new guidelines will be significant. 

Meredith Cohn, Maryland Doctors Probe 

Old Cases for Lead Exposure—CDC Guidelines 

Prompt Re- examination of Thousands 

of Children’s Medical Records, Baltimore 

Sun, May 17, 2012. The CDC decision raises 

another interesting issue whether healthcare 

practitioners will run afoul of their 

standard of care if they do not conduct retroactive 

searches. Health-care providers 

also need to be concerned whether the new 

CDC guidance parameters will call into 

question their previous actions. 

Where Do We Go from Here 

The May 16, 2012, decision by the CDC will 

have a profound effect on lead paint litigation 

because it now officially has sanctioned 

the notion that any BLL, including 

those under 10 μg/dL, can cause adverse 

health effects. This has made the job of 

plaintiffs’ attorneys much easier. 

Yet, this is certainly not the end for defendants. 

Instead, defense counsel in personal 

injury cases can work hard with their 

experts to evaluate children’s complete 

medical histories to determine whether 

an alternative medical cause may explain 

claimed injuries. They must continue to 

monitor and to evaluate all of the available 

scientific research and move to preclude 

research or file Frye and Daubert motions 

whenever appropriate. Even cases involving 

children with BLLs in excess of 10 μg/ 

dL have been lost by plaintiffs’ attorneys, 

and so defense attorneys must continue to 

press plaintiffs’ attorneys to “prove” their 

cases. 

As for insurers, most current liability 

insurance policies contain lead paint exclusions, 

thereby limiting an insurer’s potential 

liability for claims involving lead 

exposure. Given that the “reference value” 

for lead exposure is now half of the previous 

“level of concern,” however, individuals 

who were exposed to lead many years 

ago but who did not file lawsuits because 

their BLLs were under 10 μg/dL may now 

decide to do so. Assuming that they have 

not yet or only recently have reached the 

age of majority, they may still have a timely 

potential claim that reaches back many 

years. Thus, insurers that issued policies 

years ago that did not contain lead exclusions 

may find themselves subject to potential 

liability under policies that expired 

years ago. Insurers that continue to provide 

this coverage also may face an onslaught of 

claims. 



2.0 Is a Magic Number 

By Knight S. Anderson 

Yes It Is. 

It’s a Magic 

Number 

A look at how defense 

counsel and courts should 

treat several important 

concepts regarding 

evidence and expert 

testimony for purposes 

of admissibility. 

Although as Paracelsus said, “[a]ll things are poison, and 

nothing is without poison; only the dose permits something 

not to be poisonous,” the law requires more than this 

contention before an expert can opine in a court of law 

that an “exposure” to an agent more likely 

than not caused a plaintiff’s alleged injury, 

and it should require even more. With toxic 

torts, the three most important things usually 

are dose, dose and, well, dose. And the 

construct that the dose makes the poison 

is not limited to those agents that we commonly 

consider “poisons.” Rather, ubiquitous 

substances, such as water, common 

over- the- counter substances such as vitamins 

and aspirin, and even everyday foods 

such as peanut butter can become deadly 

when consumed in sufficient quantities. 

Yes, that is right, deadly. But before anyone 

blames an ingestion of an agent for a disease, 

he or she should have a scientific basis 

for doing so. It is truly the dose that makes 

a substance injurious or deadly, which may 

vary greatly among substances as demonstrated 

through scientific inquiry. In light 

of this, courts must require experts offering 

opinions on causation in litigation that 

has alleged a cause and effect relationship 

between an “exposure” to an agent and a 

disease or injury to base an opinion on a 

sufficiently established relationship and 

demonstrate that the “exposure” that a particular 

plaintiff received to a specific agent 

was sufficient, as demonstrated by science, 

to have more likely than not caused that 

plaintiff’s disease or injury. 

A plaintiff must establish a relationship 

between the specific agent and the disease 

or injury, identify the dose of a specific 

agent that a plaintiff received, demonstrate 

that the medical and scientific literature 

reliably suggests that that dose can cause 

that disease or injury, and exclude other 

causes to proceed and prevail with claims. 

This standard is grounded in the rules and 

cases law, and defense counsel must make 

sure that a plaintiff’s expert meets it, and a 

judge must act as a gatekeeper to exclude 

unreliable opinion evidence, particularly 

on causation, when science or medicine 

does not support an expert’s causation 

arguments or the evidence does not constitute 

“scientific evidence.” This article 

discusses the standards governing reliable 

scientific evidence and expert testimony 

■ Knight S. Anderson is a counsel at Tucker Ellis LLP in the Cleveland office and a member of the Trial Department and the Mass 

Tort and Product Liability Practice Group. Mr. Anderson concentrates his practice in complex litigation, including mass torts, product 

liability, toxic torts, and environmental litigation. The ideas expressed here are the views of the author and/or those expressed 

in science or the law including the credited sources and do not necessarily reflect or represent those of his law firm or their clients. 


eliability, whether a cause and effect relationship 

exists between an exposure and an 

alleged injury, generally accepted scientific 

thresholds established by epidemiological 

studies that can meet the preponderance 

of the evidence standard required to establish 

causation and from which an expert 

can reliably infer a relationship between 

the dose that a plaintiff experienced and an 

alleged injury, insufficiently alleged causal 

connections, and how defense counsel and 

courts should use these concepts for evidence 

and expert testimony admissibility 

purposes. 

In Through the Out Door 

Federal Rule of Evidence 702, which governs 

the admission of expert testimony in 

the federal courts, states: 

If scientific, technical or other specialized 

knowledge will assist the trier of 

fact to understand the evidence or to 

determine a fact in issue, a witness qualified 

as an expert by knowledge, skill, 

experience, training, or education, may 

testify thereto in the form of opinion or 

otherwise, if (1) the testimony is based 

upon sufficient facts or data, (2) the testimony 

is the product of reliable principles 

and methods, and (3) the witness 

has applied the principles and methods 

reliably to the facts of the case. 

Fed. R. Evid. 702. 

A rule 702 determination is a question 

of law for a court. Thus, when a party seeks 

to admit expert testimony, a court should 

make an initial determination during a 

preliminary hearing under Federal Rule 

of Evidence 104(a) that the requirements 

of rule 702 have been met. In Daubert, the 

Supreme Court held that Federal Rule of 

Evidence 702 imposes a special obligation 

on a trial judge to “ensure that any and all 

scientific testimony or evidence admitted 

is not only relevant, but reliable.” Daubert 

v. Merrell Dow Pharmaceuticals, 509 U.S. 

579, 589 (1993). 

In Daubert, the Supreme Court offered 

judges some guidelines regarding the 

admissibility of scientific evidence and 

then commented and expounded on that 

framework and those guidelines in General 

Electric Co. v. Joiner, 522 U.S. 136 (1997). As 

others have mentioned elsewhere numerous 

times, the Daubert factors are not an 

exhaustive list of criteria that courts must 

strictly apply to all evidence to determine 

admissibility, but rather the Court articulated 

a flexible standard for determining 

the admissibility of scientific opinions to 

ensure that expert scientific opinions are 

grounded in a reliable methodology before 

courts admit the opinions. This “flexible 

Daubert inquiry gives the [trial judge] the 

discretion needed to ensure that the courtroom 

door remains closed to junk science 

while admitting reliable expert testimony 

that will assist the trier of fact.” Amorgianos 

v. National Railroad Passenger Corp., 

303 F.3d 256, 267 (2d Cir. 2002). Daubert 

and its progeny have acquired a reputation 

as a cure for the erroneous admission 

of junk science, or at least as a shield 

against it, and these cases impose a high 

standard on plaintiffs seeking to admit 

such opinions, one of the cornerstones 

of which is reliability. A judge acting as a 

gatekeeper should apply Daubert and other 

evidentiary standards that require indicia 

of reliability before admitting an opinion 

to ensure that a jury hears only opinion 

testimony that actually constitutes “scientific 

evidence.” And in presiding over 

the reliability inquiry, a judge needs “to 

make certain that an expert… employs in 

the courtroom the same level of intellectual 

rigor that characterizes the practice 

of an expert in the relevant field.” Kumho 

Tire Co. v. Carmichael, 526 U.S. 137, 149– 

50 (1999). 

Daubert held that a trial judge is 

required to conduct a “preliminary assessment 

of whether the reasoning or methodology 

underlying the [expert] testimony 

is scientifically valid and of whether that 

reasoning or methodology properly can 

be applied to the facts in issue.” Furthermore, 

“[b]y holding that the admissibility 

of scientific testimony is governed by Rule 

104(a), Daubert clearly holds that the party 

seeking admissibility must make out more 

than a prima facie case of reliability.” In re 

Paoli R.R. Yard PCB Litigation, 35 F.3d 717, 

744, n.9 (3d Cir. 1994). And the party proffering 

the expert testimony has the burden 

of demonstrating “that the expert’s 

findings and conclusions are based on the 

scientific method, and, therefore, are reliable.” 

Moore v. Ashland Chem., Inc., 151 

F.3d 269, 276 (5th Cir. 1998) (en banc). 

Daubert requires a reliable expert opinion 

but not necessarily a correct opinion. This 

Courts have broadly 

recognized epidemiology as 

invaluable to determining 

that a cause and effect 

relationship existed and 

specifically caused a 

disease experienced by 

a particular plaintiff. 

reliability inquiry “requires some objective, 

independent validation of the expert’s 

methodology. The expert’s assurances that 

he has utilized generally accepted scientific 

methodology is insufficient.” Id. (citing 

Daubert v. Merrell Dow Pharmaceuticals, 

Inc., 43 F.3d 1311, 1316 (9th Cir. 1995) (on 

remand)). And in undertaking the reliability 

inquiry, it is the district court’s responsibility 

“to make certain that an expert… 

employs in the courtroom the same level 

of intellectual rigor that characterizes the 

practice of an expert in the relevant field.” 

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 

149–50 (1999). 

As the Supreme Court wrote in Daubert, 

“to qualify as ‘scientific knowledge,’ an 

inference or assertion must be derived by 

the scientific method. Proposed testimony 

must be supported by appropriate validation—i.e., 

‘good grounds,’ based on what 

is known. In short, the requirement that 

an expert’s testimony pertain to ‘scientific 

knowledge’ establishes a standard of evidentiary 

reliability.” Daubert, 509 U.S. at 

590. This means that a court must make 

“a preliminary assessment of whether the 

reasoning or methodology underlying 

the testimony is scientifically valid and 

of whether that reasoning or methodology 

properly can be applied to the facts in 

issue.” Id. at 592–93. In re Paoli noted that 

(1) the “proffered” witness must be a qualified 

expert; (2) the expert must testify 

about matters requiring scientific, technical, 

or specialized knowledge; and (3) the 



expert’s testimony must “fit” the facts of 

the case. In re Paoli R.R., 35 F. 3d at 741– 

42 (3d Cir. 1994). See also Kannankeril v. 

Terminix Int’l Inc., 128 F.3d 802, 806 (3d 

Cir. 1997). Additionally, in response to the 

Supreme Court decision in Daubert, Federal 

Rule of Evidence 702 was amended in 

2000: “The amendment affirms the trial 

court’s role as gatekeeper and provides 

Judgesand the lawyers 

responsible for educating 

them about the scientific 

evidence in their cases 

need to know more than 

what makes good science; 

they need to understand 

how to identify insufficient 

or even bad science and 

explain what makes it so. 


some general standards that the trial court 

must use to assess the reliability and helpfulness 

of proffered expert testimony.” Fed. 

R. Evid. 702 advisory committee’s note to 

2000 amend. 

The rule 702 inquiry requires that a 

court determine that an expert has reliably 

based his or her testimony on scientific 

methods. Daubert explains that the 

rule 702 language requiring an expert to 

testify to scientific knowledge means that 

the expert opinion must have a basis in 

“the methods and procedures of science,” 

as opposed to “subjective belief or unsupported 

speculation.” Daubert, 509 U.S. at 

590. An expert must have “good grounds” 

for his or her belief. Id. 

The factors that courts have articulated 

to guide assessing the reliability of proffered 

scientific expert testimony include 

several articulated in Daubert and in other 

decisions: (1) whether the theory or technique 

can be tested, (2) “whether the theory 

or technique has been subjected to peer 

review,” (3) whether the technique has a 

high rate of “known or potential error,” 

(4) whether standards “controlling the 

technique’s operation exist,” (5) whether 

the theory enjoys “general acceptance,” 

(6) whether there is a sufficient relationship 

between the technique and methods 

which have been established to be reliable, 

(7) whether the expert witness’ qualifications 

are sufficient, and (8) whether the 

method has been put to nonjudicial uses. 

Some courts also consider additional factors, 

including (1) whether the expert’s 

proposed testimony grows naturally and 

directly from research that the expert has 

conducted independent of the litigation; 

(2) whether the expert has unjustifiably 

extrapolated from an accepted premise to 

an unfounded conclusion; (3) whether the 

expert has adequately accounted for alternative 

explanations; (4) whether the expert 

took as much care in forming the opinion 

for the litigation as he or she would in performing 

his or her professional work in 

other contexts; and (5) whether reputation 

indicates that the field of expertise of 

the expert reaches reliable results for the 

type of opinion proffered by the expert. 

The Supreme Court in Daubert emphasized 

that the rule 702 inquiry is “a flexible one” 

and that the individual factors are neither 

exclusive nor dispositive. Courts should not 

exclude “novel” conclusions when reliable 

methodology and reliable methodological 

application underpin the conclusions. 

A court’s inquiry “must be solely on principles 

and methodology, not on the conclusions 

that they generate.” Daubert, 509 

U.S. at 595. And as explained in another 

decision, “nothing in either Daubert or the 

Federal Rules of Evidence requires a district 

court to admit opinion evidence that is 

connected to existing data only by the ipse 

dixit of the expert. A court may conclude 

that there is simply too great an analytical 

gap between the data and the opinion proffered.” 

Joiner, 522 U.S. at 147. 

Experts often rely on epidemiological 

studies to support their opinions: Epidemiology 

is the field of public health 

and medicine that studies the incidence, 

distribution, and etiology of disease 

in human populations. The purpose of 

epide miology is to better understand 

disease causation and to prevent disease 

in groups of individuals. Epidemiology 

assumes that disease is not distributed 

randomly in a group of individuals and 

that identifiable subgroups, including 

those exposed to certain agents, are at 

increased risk of contracting particular 

diseases. Michael D. Green, et al., Reference 

Guide on Epidemiology, in Fed. 

Judicial Ctr., Reference Manual on Scientific 

Evidence at 551 (3d ed. 2011). 

While some courts have pointed out that 

Daubert neither requires epidemiological 

evidence nor epidemiology- based expert 

opinions, others have referred to valid, 

reliable, and statistically significant epidemiological 

studies as “critical” and “indispensible” 

when demonstrating causation. 

For example, in evaluating the reliability 

of opinions related to cause and effect for 

exposure to Agent Orange and the chemicals 

that Agent Orange contained, Judge 

Weinstein engaged in a detailed assessment 

and discussion of scientific evidence 

and concluded that “sound epidemiological 

studies are the only useful studies 

having any bearing on causation.” See In 

re “Agent Orange” Product Liability Litigation, 

MDL No. 381, 611 F. Supp. 1223, 

1240 (E.D.N.Y. 1985), aff’d, 818 F. 2d 187 

(2d Cir. 1987). The courts have broadly 

recognized epidemiology as invaluable to 

determining that a cause and effect relationship 

existed and specifically caused a 

disease experienced by a particular plaintiff. 

See, e.g., R.E. Hoffman, The Use of Epidemiologic 

Data in the Courts; Sorenson v. 

Shaklee Corp., 31 F.3d 638 (9th Cir. 1994); 

DeLuca v. Merrell Dow Pharm., Inc., 911 

F2d 941, 954 (3d Cir. 1990), aff’d, 6 F.3d 

778 (3d Cir. 1993), cert. denied, 510 U.S. 

1044 (1994); Wilson v. Merrell Dow Pharmaceuticals, 

Inc., 893 F.2d 1149, 1154 (10th 

Cir. 1990). That said, as mentioned, the 

factors listed in Daubert are not exhaustive, 

and several courts have held that the 

legal standard does not require plaintiffs to 

prove causation only with statistically significant 

epidemiological evidence. However, 

courts should either exclude or at the 

very least subject the opinions that experts 

do not support with epidemiological evidence 

to strict scrutiny when the science 

widely accepts epidemiology as the reliable 

method for demonstrating a cause and 

effect relationship in humans in the scientific 

field involved in a case.

Defendants and defense counsel have 

waged a campaign against “junk science” 

ever since Daubert made that phrase infamous 

and common parlance among attorneys 

involved tort litigation. In addition 

to meeting other responsibilities, judges 

must now also assess the validity of scientific 

evidence. And lawyers and judges today 

continue to wrestle with whether expert testimony 

meets the criteria for admissibility. 

Judges and the lawyers responsible for 

educating them about the scientific evidence 

in their cases need to know more 

than what makes good science; they need to 

understand how to identify insufficient or 

even bad science and explain what makes 

it so. Court decisions reflect judicial recognition 

that courts in fulfilling their 

gatekeeping function have an obligation 

to keep “junk science” out of courtrooms. 

While sound public policy reasons underlie 

the broad discretion that trial courts have 

to admit evidence, sound public policy also 

requires judges to assess expert testimony 

carefully to determine both its relevance 

and reliability before the courts admit it. 

Expert testimony, whether presented by 

plaintiffs or defendants, can strongly influence 

juries. As the United States Supreme 

Court recognized, “’expert evidence can 

be both powerful and quite misleading 

because of the difficulty in evaluating it.’” 

Daubert v. Merrell Dow Pharm., Inc., 509 

U.S. at 595 (quoting Jack B. Weinstein, 

Rule 702 of the Federal Rules of Evidence 

Is Sound; It Should Not Be Amended, 138 

F.R.D. 631, 632 (1991)). For these reasons, 

neither the difficulty of the task nor any 

comparative lack of expertise can excuse 

the judge from exercising the “gatekeeper” 

duties that the Federal Rules 

impose…. To the contrary, when law and 

science intersect, those duties often must 

be exercised with special care. Today’s 

toxic tort case provides an example. 

To the contrary, when law and science 

intersect, those duties often must be 

exercised with special care. 

Joiner, 522 U.S. at 148 (J. Breyer concurring). 

Blinding Me with Science 

Tort law uses the term “specific causation,” 

sometimes called “individual causation,” to 

refer to which particular events will cause 

or may have caused a particular injury in 

a specific plaintiff. Usually, for a plaintiff 

to win damages in a tort case, the plaintiff 

must prove both general and specific causation. 

To win damages the law requires 

sufficient scientific support for any alleged 

claims for injury resulting from an alleged 

exposure to a toxic substance, and defense 

counsel and the courts must make sure 

plaintiffs meet this requirement. Plaintiffs 

and their experts must establish that science 

supports the existence of a cause and 

effect relationship, the plaintiff received a 

particular dose of the specific agent, and the 

medical and scientific literature has identified 

a link between that particular dose of 

that specific agent and the particular alleged 

disease or injury. A reliable, admissible expert 

opinion on the issue of causation in a 

toxic exposure case must demonstrate a reliable 

basis for the cause and effect relationship. 

The proponent of specific causation 

evidence must show that the “exposure” experienced 

by a plaintiff to a specific agent 

has been reliably shown in science and medicine 

to cause the particular alleged injury. 

As mentioned, experts often support 

specific causation testimony by testifying 

about epidemiological studies. Epidemiological 

studies have conceptual roots in 

scientific experimentation. The “scientific 

method” is the established approach used 

by epidemiologists and other scientists to 

study the potential existence of a cause 

and effect relationship. Generally speaking, 

as with all science, epidemiology depends 

on measurements, on precision, and 

on validity. An epidemiological study without 

proper measurements does not follow 

accepted scientific practice, and the scientific 

community will not accept a study 

without proper measurements or that other 

scientists cannot verify independently because 

other researchers in the community 

cannot confirm its conclusions. Epidemiological 

studies help us understand disease 

causation and the likelihood that a population 

exposed to an agent may develop disease, 

and they help us identify and prevent 

disease in groups of individuals. These studies 

express risk or relative risk, interpreting 

risk on a more likely than not basis that is 

well-suited to the preponderance of the evidence 

legal standard. 

An epidemiological study generally 

starts with an initial observation, sometimes 

from a “case” report that—a person 

with disease, referred to as a “case,” 

A properepidemiological 

study must include clear 

definitions of both a disease, 

or more generally, the 

outcome, and the exposures 

that are under study. 

received a particular exposure. From there, 

a cause and effect hypothesis is developed. 

The hypothesis is then tested with properly 

conducted research studies with appropriate 

referent groups. These studies must 

rigorously test the hypothesis and seek to 

establish reproducibility. When epidemiologic 

experiments are feasible, they are 

designed to reduce variation from extraneous 

factors, meaning things not under 

study, compared to study factors. Most epidemiological 

studies are nonexperimental 

because of ethical and financial restrictions. 

Nonetheless, the goal of nonexperimental 

studies is to obtain valid evidence 

about the hypothesis under study. 

A proper epidemiological study must 

include clear definitions of both a disease, 

or more generally, the outcome, and the 

exposures that are under study. The outcome 

must be defined in a manner that is 

accepted within the medical community, 

typically based on physiological and pathological 

criteria. The diagnostic criteria must 

be reliably and consistently applied to all 

subjects included in the study. The exposure 

must be defined in such a way that 

the determinations of which subjects have 

been exposed are both reliable and valid. 

Researchers must describe the criteria for 

outcomes and exposures with sufficient 

detail so that other qualified scientists can 

replicate the research methods. 

There are two basic types of nonexperimental 

epidemiological studies: cohort 

studies and casecontrol studies. A cohort 

study is closely related conceptually to an 

experiment. Different exposure groups are 

compared to find out whether their outcomes 

differ. A casecontrol study compares 



people who have the outcome, or the disease, 

to those who don’t have the outcome to 

find out whether the groups differ in terms 

of their past exposures. A person without 

the disease is referred to as a “control.” In 

both types of study, there is a comparison 

or referent group. A principal goal of incorporating 

a referent group is to reduce variation 

due to extraneous factors—things not 

Because a plaintiff needs 

proof of specific causation 

to satisfy the plaintiff’s 

burden of proof, specific 

causation proof often 

becomes a litigation focus. 


under study—compared to study factors. A 

cohort study typically begins by identifying 

a group consisting of individuals who have 

been exposed to a particular substance— 

a potential cause of a disease—and a referent 

group consisting of individuals who 

have not been exposed. The epidemiologist 

then compares the outcomes, meaning, for 

instance, the disease rates, in the exposed 

and unexposed groups. Case- control studies 

are derived from a source population, 

which hypothetically represents a source 

population in which a cohort study could 

be conducted. The cases are then identified 

and their previous exposure status is 

ascertained. The control group is selected 

as a representative sample of the source 

population that gave rise to the cases. The 

epidemiologist then compares the odds of 

exposure among the cases to the odds of exposure 

among the controls. 

Cohort and casecontrol studies seek to 

determine whether an association exists 

between an exposure and the disease 

being studied. An association exists when 

exposure and outcome—disease—occur 

together more frequently than would be 

expected by chance. For example, in a 

cohort study, there is an association when 

the disease rate in the exposed group is 

higher than the disease rate in the unexposed 

group. The disease rate in the unexposed 

group represents the disease rate due 

to extraneous factors that are not under 

study and that are randomly distributed in 

the population and expected by chance. In 

a casecontrol study, an association exists 

when the frequency of exposure, or more 

correctly, the odds of exposure, is higher 

among the cases than it is among the controls. 

The existence of an association in an 

epidemiological study does not mean that 

there is cause and effect relationship. Inferences 

about cause and effect require additional 

considerations. 

Diseases have background rates in the 

general population so that in any given 

group of people someone would expect to 

find a certain number of cases of the disease 

in the absence of the exposure under 

study. Simply finding that some people who 

have experienced a particular exposure 

also have the disease does not prove any 

relationship between the two and cannot 

serve as a basis for a scientist to conclude 

that the exposure is associated with the disease, 

much less cause the disease. Insofar 

as the disease has a background rate in the 

general population, the crucial question is 

whether people with a particular exposure 

develop the disease more frequently than 

people without the exposure, and that can 

be determined only in properly conducted 

epidemiological studies. 

A central requirement of epidemiological 

studies is to avoid bias. Bias is the 

introduction of systematic error into the 

risk estimate as a result of improper study 

design. “Selection bias” occurs when cases 

are chosen in a manner that is not independent 

of their exposures, or when the manner 

in which controls are chosen makes 

them unrepresentative of the source population 

from which the cases arose. In either 

instance, selection bias can introduce a systematic 

error into the estimated association 

between outcome and exposure. “Information 

bias” occurs if the data is obtained in a 

different manner across study groups. For 

example, if the diagnostic evaluation, the 

diagnostic criteria, or likelihood of seeking 

medical care differs between exposed 

and unexposed subjects, the exposed group 

may have a higher chance of being classified 

as cases than the unexposed group simply 

because they received different medical 

care. A second example would be if cases 

and controls were determined to have been 

exposed using different criteria or based 

on differences in the investigations of past 

exposures. If more or different effort were 

expended in determining the past exposures 

of cases than of controls, this systematic 

difference would introduce error 

into the estimated association between 

outcome and exposure. Either type of bias 

will call the reliability of a study into question. 

The existence or absence of an association 

is measured mathematically as a 

“relative risk.” In a cohort study, that relative 

risk can be expressed numerically as a 

standardized incidence ratio (SIR), a standardized 

mortality ratio (SMR), or a proportionate 

mortality ratio (PMR). Each is 

calculated by dividing the number of incident 

cases of disease (or deaths) by the 

number of incident cases of disease (or 

deaths) that would be expected if the study 

population had the same disease rate (or 

mortality rate) as the referent population. 

In a casecontrol study, the potential 

existence of an association is measured by 

the calculation of an odds ratio (OR). An 

odds ratio is determined by comparing the 

odds that a case (a person with a disease) 

was exposed, to the odds that a control (a 

person without the disease) was exposed. 

If, for example, among 10 cases five were 

exposed and five were not exposed, the 

odds of exposure among cases would be 

5/5=1.0. If from among 12 controls, three 

were exposed and 9 were not exposed, the 

odds of exposure among controls would be 

3/9 = 0.33. The odds ratio (OR) is the ratio 

of the odds among cases to the odds among 

controls. In this example, this would mean 

that OR = 1.0/0.33 = 3.0. 

“Relative risk” is an umbrella term used 

to describe the various measurements of 

association used in both cohort and casecontrol 

studies, including standardized 

mortality ratio (SMR), standardized incidence 

ratio (SIR), proportionate mortality 

ratio (PMR), or odds ratio (OR), among 

others. 

A casecontrol or cohort study that 

shows a relative risk of less than 1.0 suggests 

that the agent is associated with a 

reduced risk of the disease or mortality. 


shows a relative risk of 1.0 indicates that 

no association between the agent and the 

disease or mortality exists.


shows a relative risk above 1.0 suggests the 

existence of an association between the 

agent and the disease or mortality. 


shows a relative risk of 2.0 indicates a twofold 

association between the agent and the 

disease and that one-half, or 50 percent, 

of the incidence of disease or mortality is 

attributable to the agent and one-half is 

attributable to other factors, or a doubling 

of the risk. This suggests that the disease is 

just as likely to be related to the exposure 

to the agent as it is to be unrelated to the 

exposure to the agent, a 50/50 proposition 

of causation. 

A case-control or cohort study that 

shows a relative risk greater than 2.0 indicates 

that more than one-half or 50 percent 

of the incidence of the disease or mortality 

is attributable to the agent and less 

than one-half is attributable to other factors. 

This suggests that more likely than 

not the disease is related to the exposure 

to the agent, or a > 50 percent chance of 

causation. 

Because a plaintiff needs proof of specific 

causation to satisfy the plaintiff’s burden 

of proof, specific causation proof often 

becomes a litigation focus. Proof of specific 

causation generally has two elements. 

A plaintiff initially must show that the level 

of an agent that he or she was exposed to under 

the circumstances of exposure, meaning 

the exposure frequency, dose, duration, 

and intensity, can cause the illness that he 

or she developed. This is when epidemiology 

becomes vitally important. And “there 

plainly is a hierarchy to these different indirect 

forms of toxic effect evidence. Epidemiology 

is at the top, and structural similarity, 

in vitro testing, and case reports are at the 

bottom.” Federal Judicial Ctr., Reference 

Manual on Scientific Evidence, supra. Additionally, 

to use epidemiological studies 

properly as the basis to prove specific causation, 

the proponent must show that the 

exposure did more than simply increase 

the hypothetical risk of injury. Rather, as 

logic, science, and the law suggest, and as 

some courts have held, a study must show 

at least a doubling of the risk of the harm, 

a “more likely than not” chance of association. 

Courts, borrowing scientific terminology, 

often refer to the doubling of the 

risk as a “relative risk” of greater than two. 

Daubert v. Merrell Dow Pharms., Inc., 43 

F.3d 1311, 1321 (9th Cir. 1995) (finding that 

for epidemiological testimony to be admissible 

to prove specific causation, there must 

have been a relative risk for a plaintiff of 

greater than two). Many courts have “found 

that the requirement of a more than 50 percent 

probability means that epidemiological 

evidence must show that the risk of an 

injury or condition in the exposed population 

was more than double the risk in the 

unexposed or control population” to establish 

by a preponderance of the evidence or 

“more likely than not” standard that there 

is an association sufficient to consider causation. 

Merrell Dow Pharms., Inc. v. Havner, 

953 S.W.2d 706, 714 (Tex. 1997). 

Add It Up 

As noted above, toxic exposure cases are, or 

at least they should be, about dose and science. 

And if the circumstances of a plaintiff’s 

exposure cannot be demonstrated and 

shown by reliable science to present a statistically 

significant increased risk that that 

“exposure” more likely than not caused the 

disease, in the words of Robert DeNiro as 

Al Capone in The Untouchables, “You got 

nothing. You got nothing in court…. Nothing. 

NOTHING.” Not only must expert 

opinion testimony on the issue of causation 

be based upon “something,” a plaintiff 

must show that this “scientific” knowledge 

and the methodology used to reach an 

ultimate conclusion is reliable, generally 

accepted, or both. 

In law, the preponderance of the evidence 

standard usually requires just enough evidence 

to make it more likely than not that 

what a party alleges is actually true. While 

many courts do not translate the standard 

statistically, it is often described as > 50 

percent or 51 percent. As mentioned above, 

the existence or absence of an association 

between an exposure to an agent and a 

resulting injury can be measured mathematically 

and expressed as a “relative 

risk,” an “odds ratio,” or an “attributable 

LMI 

Litigation Management,Inc. 



risk.” Again, “relative risk” is an umbrella 

term used to describe the various measurements 

of association used in both cohort 

and casecontrol studies mentioned above, 

which can include a standardized mortality 

ratio (SMR), a standardized incidence 

ratio (SIR), a proportionate mortality ratio 

(PMR), an odds ratio (OR), others, or a 

combinations of them. 

Testimony offeredon 

these topics moves from the 

scientific to the hypothetical 

and has spawned a variety 

of unspecific and very 

unscientific “catch phrases” 

summarizing the bases of 

causation opinion theories. 

As mentioned above, a scientific study 

(casecontrol or cohort study) that shows 

a relative risk of 2.0 indicates a two-fold 

association between the agent and the disease 

or suggests a doubling of the risk that 

the agent, in fact, will cause the disease. 

This means that the incidence of the particular 

disease or mortality is attributable 

to the agent and one-half is attributable 

to other factors. Thus a relative risk of 2.0 

suggests that the disease is just as likely to 

be related to the exposure to the agent as 

it is to be unrelated to the exposure to the 

agent. Again, as mentioned above, a study 

that shows a relative risk of greater than 

2.0 indicates that more than one-half of the 

incidence of the particular disease or mortality 

is attributable to the agent, in other 

words, more than 50 percent, and less than 

one-half is attributable to other factors. 

Thus a relative risk of > 2.0 suggests that 

more likely than not the disease is related 

to the exposure to the agent: a > 50 percent 

chance of causation. A relative risk of 

> 2.0 is equivalent to the “more likely than 

not” preponderance of the evidence legal 

standard. To learn more about the “more 


likely than not” standard, epidemiological 

evidence, and a “relative risk” of 2.0, see 

DeLuca v. Merrell Dow Pharms., Inc., 911 

F.2d 941, 957–59 (3d Cir. 1990). 

While sometimes referred to as a “talisman,” 

there is nothing particularly magical 

in science or epidemiology about a relative 

risk of 2.0, particularly when compared 

with a 1.99999999 or a 2.00000001. However, 

in a toxic tort case, 2.0 is the actual 

scientific statistic delineating the difference 

between more likely and less likely and the 

place where relative risk, indeed, becomes 

a magic number. 

Take Another Look 

Also worth reexamining, and essential 

if you are litigating your case in a federal 

court, is the Federal Judicial Center Reference 

Manual on Scientific Evidence. See 

Reference Manual on Scientific Evidence 

(3d ed. 2011). In 2011, the National Academy 

of Sciences published the third edition 

of the Reference Manual on Scientific 

Evidence, which was created by a panel of 

judges, scientists, engineers, and doctors 

and serves as a resource for judges to consult 

when dealing with scientific evidence. 

The topics covered in the third edition of 

the manual are the admissibility of expert 

testimony, how science works, forensic 

identification expertise, DNA identification 

evidence, statistics, multiple regression, 

survey research, estimation of economic 

damages, exposure science, epidemiology, 

toxicology; medical testimony, neuroscience, 

mental health evidence, and 

engineering. Many judges, both state and 

federal, rely on this manual as the first 

and perhaps even the last word on certain 

issues. The reference manual addresses the 

necessary link between exposure and disease 

and how that causal nexus may be 

established, reliable exposure assessment, 

and the valid and reliable scientific reasoning 

necessary to support the link between 

the exposure of a plaintiff to the specific 

agent at issue and the disease in that plaintiff. 

The manual offers questions relevant 

to evaluating science in a legal context, including 

the following: 

• What are the sources of exposure 

• What are the specific agents involved in 

the exposure 

• What is the duration of exposure, and 

what is the basis for that conclusion 

• What are the pathways from the source 

to the exposed individuals 

• Have those pathways been established 

• What is the concentration of the agent in 

the media with which the exposed population 

came into contact 

• What is the basis for these answers Direct 

measurement Estimates Modeling 

• If models or estimates were used, how 

reliable are they 

• What is the variability over time in concentrations 

in the media of concern 

• What is the variability over time in concentrations 

in the pathways of concern 

• How has the variability been determined 

• What is the variability among members 

of the population in their exposure to 

the chemical of concern and how is this 

known 

• What dose, over what period of time, 

by which routes, has the individual 

received 

• What cumulative dose did the individual 

receive 

• What calculations and evidence support 

this documentation 

• What is the likely error rate in the exposure 

estimates 

• What uncertainties are associated with 

the dose and duration findings 

• What has been omitted from the exposure 

assessment, and why 

• Has the cumulative dose of the exposure 

that the individual received to this specific 

agent been shown by reliable and 

statistically significant scientific evidence 

to cause the particular disease 

2.0 Is a Magic Number 

Before an expert may offer an opinion that 

an “exposure” to an agent was more likely 

than not the cause of an alleged injury, a 

plaintiff must show that the plaintiff was 

“exposed” to a quantifiable estimated dose 

of a specific agent and that that dose of 

that specific agent has been shown by reliable 

scientific evidence to more likely than 

not cause the injury. Thus, there should be 

reliable epidemiological studies in the peerreviewed 

published medical and scientific 

literature that suggest that the dose of that 

specific agent creates a statistically significant 

increased relative risk of greater than 

2.0 of developing the particular alleged 

injury. 

Magic Number, continued on page 81


Be Armed with 

Good Science 

By Douglas R. Morr 

and Gary J. Heydinger 

Defending Claims 

Against ROV 

Manufacturers 

Reliable and scientifically 

valid information on 

how restraint systems 

work in real-world events 

can be the backbone of 

a strong defense against 

opinions based on 

inaccurate theories. 

One of the critical components of any successful product 

liability defense is comprehensive knowledge of the product. 

This includes having a firm understanding of the performance 

characteristics, capabilities, and limits of the 

product. Knowledge of this type coupled 

with an evaluation of the product under 

circumstances specific to a claimed event 

is desirable. Inaccurate opinions and 

accusations can be combated with clear, 

comprehensive, and credible scientific 

information. These statements are true for 

all products, including Recreational Off- 

Highway Vehicles (ROVs). 

ROVs, also known as side by sides, differ 

from on-road passenger vehicles in 

both their intended uses and their features. 

In general, ROV customers want vehicles 

with superior levels of “off- roading” capability, 

the ability to maneuver through 

narrow spaces, and a tight, low-speed 

turning radius. Accordingly, ROVs are 

designed to travel over rough terrain with 

a track width narrow enough to fit on 

many existing off- highway trails. To satisfy 

this demand, manufacturers provide 

high ground clearances, large ranges of 

suspension deflections, large low- pressure 

tires, and responsive steering. Some consumers 

also want vehicles that are capable 

of higher speeds. This desire has led to the 

development of more powerful ROVs. 

As with many cases involving onhighway 

vehicles, accidents involving ROVs 

are often attributed to insufficient levels of 

stability or safety. Assertions such as “The 

vehicle’s center of gravity height is too 

high and its track width is too narrow,” 

or “The vehicle’s tip-up resistance is not 

high enough,” or “The vehicle’s occupant 

restraint system is inadequate,” are often 

made regarding ROVs. Although these 

types of allegations are generally vague, 

they must be addressed to defend a product 

liability case successfully. 

Claims against ROV manufacturers stem 

from allegations of one or more occupants being 

injured while riding in an ROV, and purportedly 

involve one or more of the following: 

■ Douglas R. Morr, M.S., P.E., leads S-E-A’s Biomechanical Group in conducting investigations and research 

relative to injury mechanisms and causation. He oversees research and testing programs at S-E-A’s Research 

Center, including Roll Simulator testing of occupant response and protection, as well as Minor Impact Simulator 

and Drop Tower testing. Gary J. Heydinger, Ph.D., P.E., is the Director of Vehicle Dynamics for S-E-A, 

and was integral to the design of the Vehicle Inertia Measurement Facility (VIMF), which measures vehicle CG 

height, moments of inertia and SSF for automotive manufacturers and the National Highway Traffic Safety Administration’s 

New Car Assessment Program. 



• low static stability factor (SSF); 

• inadequate rollover resistance; or 

• inadequate occupant protection. 

Low Static Stability Factor (SSF) 

Opposing experts, at times, may compare 

ROV static characteristics to on-road passenger 

vehicle safety metrics. For example, 

they might claim that an ROV is 

Today,appropriate 

dedicated equipment 

exists that can be used 

to recreate real-world 

motions in an ROV in a 

laboratory environment. 

Tests such as these 

can be used to quantify 

and comprehend the 

performance of the 

restraint systems better. 

flawed because its static stability factor 

(SSF)—a vehicle’s center of gravity (CG) 

height divided by one-half of its track 

width—is too low. In reality, most ROVs 

have a lower SSF than on-road passenger 

vehicles. The function and utility of ROVs 

and on-road passenger vehicles are quite 

different and, therefore, comparing their 

static safety metrics, such as SSF, is not 

justifiable. 

Correctly determining a vehicle’s CG 

height to calculate its SSF is no trivial 

task. There are numerous opportunities 

for error, and simplifying assumptions can 

lead to incorrect results. Yet, to address 

claims made against a vehicle’s CG height 

and SSF properly, it is necessary to have 

accurate measurements. With appropriate 

equipment and adherence to proper techniques, 

it is possible to measure the effect 

that certain design parameters may have 


on an ROV’s CG height, SSF, and inertia 

properties. This includes, but is not limited 

to, the installation of tires not recommended 

by the manufacturer, applying tire 

pressures counter to what is prescribed, or 

exceeding the manufacturer’s limits for 

occupant and cargo loading. 

Inadequate Rollover Resistance 

Cases against ROV manufacturers may 

also involve claims that the vehicles do not 

have adequate rollover resistance based 

on their performance during severe driving 

maneuvers. Allegations that an ROV 

is flawed because it tips up at lateral accelerations 

below those necessary to tip up 

an on-road passenger vehicle suffer from 

the same lack of foundation as the low SSF 

claims. The two different vehicle classes 

have significant differences in their function 

and utility. Therefore, it is imperative 

to know the limits of a specific ROV’s capabilities 

during maneuvers that take it to the 

threshold of tipping up, and as importantly, 

to know what type of driver inputs are necessary 

to do so. 

Equipping an ROV with test instrumentation 

and “putting it through its paces” in 

a suite of dynamic field tests can answer 

the necessary questions regarding its overall 

lateral stability and rollover resistance. 

More importantly, dynamic field- testing 

can be used to demonstrate the magnitude 

of driver inputs, such as the vehicle speed 

and steering requirements necessary to 

take the vehicle up to its limits of response. 

This knowledge is useful in gauging the 

inherent margin of safety that a vehicle 

has under various driver conditions, including 

while being driven on various offroad 

terrains. Further, this information 

can be helpful to address how a vehicle 

responds under driver inputs that might 

be made by an alert, responsible, and prudent 

driver, as well as indicate what types 

and ranges of driver inputs are necessary to 

cause or to contribute to a particular accident. 

Finally, data obtained can be applied 

to address differences between ROVs and 

on-road vehicles. 

Inadequate Occupant Protection 

Sometimes lawsuits against ROV manufacturers 

involve assertions that the vehicles 

do not have adequate occupant restraint 

systems. Allegations may posit that ROV 

original equipment manufacturer (OEM) 

seat belts, hip and shoulder restraints, 

doors and nets, or a combination of these 

are inadequate or defective, and plaintiffs 

allege that they can show “redesigns” that 

could have prevented the injuries from 

occurring. Often the allegations and the 

“redesigns” are not based on facts supported 

by physics or by rigorous biomechanical 

evaluation. Clearly, the foremost 

issue to evaluate is whether or not the 

restraint system was present and properly 

used at the time of an accident. It is necessary 

to have a sound understanding of the 

safety benefits and characteristics, as well 

as the limits, of each restraint and occupant 

protection component on the ROV. 

Even more beneficial is knowing how the 

elements work together to provide overall 

occupant protection and thereby prevent 

injury. 

The translational and rotational forces 

that act on an ROV and its occupants before 

and during an accident lead to very complex 

vehicle and occupant motions, displacements, 

velocities, and accelerations. 

For example, in most ROV rollover situations, 

it is not sufficient simply to test or 

model the vehicle and occupant as they 

might respond during a “pure roll” motion; 

most rollovers involve important components 

of longitudinal and lateral accelerations 

and motions as well. Studies of 

three- dimensional states of motion and 

forces are required to evaluate occupant 

restraint systems properly. Tipping (rolling) 

a vehicle at 45 degrees, or to any other 

quasi- static angle for that matter, without 

any longitudinal or lateral acceleration, 

is not adequate to determine how well a 

restraint system works during an accident 

scenario. Doing so may result in misleading 

conclusions. Today, appropriate dedicated 

equipment exists that can be used 

to recreate real-world motions in an ROV 

in a laboratory environment. Tests such as 

these can be used to quantify and comprehend 

the performance of the restraint systems 

better. 

Being armed with reliable and scientifically 

valid information on how restraint 

systems actually work in real-world rollover 

events can be the backbone of a strong 

defense against opinions based on inaccurate 

theories or science.

Science is a verb. 

While S-E-A has an incredibly well-educated staff, our 

work is anything but academic. We apply our disciplines 

to the real world. The world where hands get dirty. The 

world where things break, burn, collapse and collide. 

In the real world, the answers to what happened are 

often hidden in a maze of twisted metal. Or buried in a 

mountain of dust and debris. They may be concealed in 

a heap of smoldering ashes or lying in the dark 

on the ocean’s floor. The answer is there for 

those who know where to look and have the 

ability to recognize what they see. This requires 

objectivity along with equal parts of expertise, 

experience and open-mindedness. Qualities we, at 

S-E-A, demand from everyone placed on an 

assignment, whatever their degree or title. After the 

team reveals the cause, they are also quite capable of 

explaining the facts to the layman, in clear concise 

verbiage and demonstrations that have been an 

exceedingly useful tool in courtrooms across the 

country for more than 40 years. 

Visit www.SEAlimited.com 

or call Jason Baker at 

800-782-6851 for more details. 

Scientific Expert Analysis 

 

© 2012

Writers’ Corner 

Let’s Try This Again 

Motions for Reconsideration 

By Michael F. Smith 

An e-mail or envelope finally arrives from a court, and 

the news isn’t good. So after you digest the ruling and 

analyze it with your client, what’s next 

In the no-man’s-land between running up the white 

flag and full-blown appellate battle lies the motion for 

reconsideration or rehearing. It’s a long shot in the best 

of situations, but under the right circumstances, it can 

pay off. 

As with any court filing, the first things to know are 

the basics. Check both the primary and local court rules 

for technical requirements such as page limits, timing, 

and title. For instance, some court rules distinguish 

between “reconsideration” and “rehearing.” Beyond that, 

a few writing tools can help smooth the grade a bit on the 

decidedly uphill climb. 

First, know what you’re up against, and argue to it. 

Does your court grant reconsideration only for “manifest 

error” or some other heightened standard How does 

it define that Some set the bar high, reconsidering only 

in “highly unusual circumstances,” that is, for “newly 

discovered evidence… [or] clear error, or if there is an 

intervening change in the controlling law.” Carroll v. 

Nakatani, 342 F.3d 934, 944 (9th Cir. 2003). Others have 

wide discretion, and can offer a failed motion a “second 

chance” even though nothing has changed. See In re 

Moukalled Estate, 714 N.W.2d 400, 405 (Mich. Ct. App. 

2006). Knowing the standard and how it’s practically 

applied will help you frame and argue the issues to raise. 

Second, pick your battles. So the court’s opinion was, 

as you told the client, so riddled with errors that a firstyear 

law student wouldn’t have written it. Set that aside; 

you’re not likely to achieve much raising a laundry list of 

mistakes. If you identify several fundamental mistakes 

that you can discuss in readable fashion within the page 

limit, nothing says that you can’t. But human nature 

being as it is, you’re more likely to convince a court that 

it made one or two palpable errors rather than seven. 

Third, use tone to convey what the appellate court will 

hear. As the Texas Court of Appeals noted, one function 

of a reconsideration motion is to provide “notice that a 

party is dissatisfied with a final order and that the party 

will seek review if the ruling is not changed.” Dolenz v. 

Texas State Bd. of Medical Examiners, 899 S.W.2d 809, 

■■ 

Michael F. Smith is principal of The Smith Appellate Law Firm in Washington, 

D.C., and concentrates his practice on appellate litigation and trial- level tactical and 

strategic consulting. He is a member of the DRI Appellate Advocacy Committee. 

811 (Tex. Ct. App., 1995). Candidly and directly tell a 

court what it did wrong, and how it can make it right, 

now. 

Fourth, educate. Maybe a court misunderstood the 

facts, or the law, or their interplay—perhaps even helped 

along by your own earlier motion papers. Use reconsideration 

as a chance to explain things more clearly, and 

address points that a court inadequately grasped. As 

Bill Gates has said, “Your most unhappy customers are 

your greatest source of learning.” The adverse opinion 

was your unhappy customer. Let your reconsideration 

motion serve the same role for a court. 

Fifth, buttress the record for appeal. Many reconsideration 

rules limit new facts or legal argument to those that 

couldn’t have been brought to a court’s attention earlier 

with reasonable diligence. See, e.g., D. Ariz. L.R. Civ. 

7.2(g)(1). That principle can be easier to state than apply, 

though, and if the record doesn’t contain some evidence 

that could be relevant on appeal, a motion for reconsideration 

can offer a way to admit it. Courts often review 

denials of reconsideration under a high standard, but 

having material, argument, or both in the lower court 

record at the eleventh hour beats having to convince an 

appellate court why it should address an unpreserved 

issue, or newly raised evidence. 

Sixth, don’t get cute or overthink the consequences 

associated with filing a motion for reconsideration. One 

favorite reason for not seeking reconsideration is, “I don’t 

want to give the trial judge a chance to fix his (or her) 

mistake.” But an appeal is likely to succeed or fail due 

to its substantive merit, and if your main issue is a “gotcha” 

or debater’s point, an appellate court may well take 

a pass under the guise of harmless error. You’d speak up 

if a surgeon left something behind; there’s no reason to 

treat an errant trial judge any differently. 

Seven, know when to move on. Or as Mich. Ct. Rule 

7.313(F) instructs, “[t]he clerk shall refuse to accept for 

filing any motion for reconsideration of an order denying 

a motion for reconsideration.” 

Going back to a court that has just rejected your best 

effort isn’t high on any litigator’s list of favorite activities. 

But judges aren’t in the business of purposely making 

erroneous decisions, and given the time, the expense, 

and the effort involved in mounting a full-scale appeal, a 

reconsideration motion in the right situation can be the 

stitch in time that saves nine. 


DRI connects you with your peers and 

gives access to education like no other. 

Claims Executives* can attend DRI seminars at no cost. 

* Any member of DRI employed as a claims professional by a corporation or insurance company, who spends a substantial portion of his 

or her professional time hiring or supervising outside counsel in the representation of business, insurance companies or their insureds, 

associations or governmental entities in civil litigation will be entitled to free attendance at any DRI program. 

Any nonmember lawyer eligible for free DRI programming employed as a claims professional by a corporation or insurance company, 

who spends a substantial portion of his or her professional time hiring or supervising outside counsel in the representation of business, 

insurance companies or their insureds, associations or governmental entities in civil litigation, may attend one free DRI program 

provided that such lawyer is sponsored by a DRI member and accompanied at the seminar by the sponsoring DRI member. 

A nonlawyer, vice president or manager in charge of hiring or supervising outside counsel nationally or regionally (multistate) for a 

corporation, third party administrator or insurance company is eligible to attend one free seminar annually provided that such 

individual is sponsored by a DRI member** and accompanied by the sponsoring DRI member at the seminar. 

** Must be an active Individual Member and registered for the seminar. Sponsorship is limited to one nonmember claims executive per 

member per seminar. 

Offer excludes DRI Annual Meeting. 

dri.org

Think Globally 

Another Step Forward 

European-Style Class Actions 

By Dr. Thomas Rihm 

The prospect of European- style class actions took 

another step forward recently when the European Parliament 

passed a resolution emphasizing the need to 

legislate a standard approach toward collective redress, 

that is, class actions. This column provides an overview 

of this recent resolution and an update on existing class 

action laws throughout the European Union. 

In this recent resolution, the European Parliament 

underscored the need for a judicial framework applicable 

to all legal entitlements that would ask courts in Europe 

to deal with mass claims according to a uniform, “horizontal 

framework” across the entire European Union. 

Earlier efforts by the European Commission on collective 

redress mainly focused on consumer protection 

and competition law and used different approaches in 

different sectors. In the recent resolution, the European 

Parliament also resolved that it should not introduce 

American- style, U.S. class actions through legislation 

that would adopt certain practices such as extensive 

pretrial discovery procedures, punitive damages, contingency 

fee arrangements, and the U.S. legal system 

tradition that parties must bear their own legal costs 

regardless of the outcome of litigation. 

The European Parliament emphasized in the resolution 

the importance of taking a opt-in approach that 

required an action for collective redress to identify and 

to make known all claimants seeking the collective 

redress when they filed a claim for collective redress, as 

opposed to the U.S. framework, which provides res judicata 

for all claimants who have not opted out before litigants 

agree to a settlement or a court hands down an 

award. The European Parliament resolution offers guidance 

to the European Commission in its further legislative 

work on collective redress in 2012 and the following 

years. 

While the “top-down approach” taken by the European 

Commission and the European Parliament has 

received well- deserved public attention over the last 

years, a majority of 27 European Union members countries 

had passed almost unnoticed collective redress legislation 

in the last two decades, including, among others, 

France in 1992, Portugal in 1995, the United Kingdom, 

■■ 

Dr. Thomas Rihm is a senior partner with the mid-sized business law firm of 

Thouvenin Rechtsanwälte in Zürich with more than 20 years of experience in dispute 

resolution and arbitration, particularly focusing on shareholder litigation battles 

and disputes dealing with private company takeovers and D & O liability cases. Think Globally, continued on page 

in the French- influenced and Italian- influenced parts of 

81 


without Scotland, and Spain in 2000, Sweden in 2003, 

Germany and The Netherlands in 2005, Italy and Greece 

in 2007, Bulgaria in 2006 and 2008, Denmark in 2008, 

and Poland in 2010. 

It does not come as a surprise that these collective 

redress regimes are as diverse as these European Union 

member countries. Significant differences exist, to name 

just a few, in terms of available legal reliefs, such as mere 

injunctive judgements as opposed to judgements also 

granting damage awards; in terms of how victims have 

the right to sue, such as only through consumer associations 

or as individual claimants grouped together in a 

class of claimants; in terms of procedures, such as optin 

as opposed to opt-out classes; or whether the regimes 

permit lawyers’ contingency fee arrangements or thirdparty 

litigation funders. 

For example the Swedish Class Action Act of 2003 

offers a collective redress system that comes close to U.S. 

class actions under rule 23 of the U.S. Federal Rules of 

Civil Procedures. Then there is France, which entrusts 

claim enforcement, including damage compensation, 

only to governmentally approved nonprofit associations 

in the consumer and financial market law areas. 

Austria has a system similar to France whereby not- forprofit 

associations can represent one or more claimants 

through an assignment of claims. 

The United Kingdom has taken yet another but rather 

innovative approach through its group litigation order 

(GLO) or GLO- system, a procedural judicial management 

mechanism that allows a judge to resolve certain 

factual or legal issues, or both, common to a variety of 

claimants by an award order, such as the illegality of 

certain market actions or the causality between illicit 

actions and resulting damages. However, claimants 

and claimants’ entitlements are not collectivized in any 

form, so claimants remain individual trial parties from 

the moment that they file their court actions until a dispute 

is resolved, though individual claimants may benefit 

from a positive GLO award. 

Switzerland enacted in 2011 a new Civil Procedural 

Code, thereby replacing the 26 civil procedural codes 

corresponding to the 26 different Swiss “cantons,” akin 

to federated states, in effect for more than a 100 years 

and under which particular difficulties existed in reconciling 

the trial systems of the Latin cantons existing

Defense Ethics and Professionalism 

An Entitlement of the Profession 

The Pro Bono Call of Professionalism 

By Thomas A. Gilligan, Jr. 

Not too long ago, I accepted a pro bono case in which 

I agreed to represent a woman seeking a domestic abuse 

order for protection. When I arrived at the courthouse, I 

saw a woman sitting alone in a conference room. Guessing 

that it might be my client, I knocked on the door and 

entered the room. I asked her name and told her that I 

would be her lawyer. She immediately burst into tears. 

She then apologized and said that she thought I was 

going to tell her that I represented her abuser. I was able 

to help her get the relief that she and her children needed. 

She thanked me for being her lawyer. I walked out of the 

courthouse that morning with a renewed understanding 

of the how a lawyer can affect someone vulnerable, 

scared, and poor. She did not thank me because I was 

particularly capable, or even because I was able to help 

her. She thanked me because I showed up. 

Model Rule 6.1 reminds lawyers of their “professional 

responsibility” to provide pro bono legal services. See 

Model Rules of Prof’l Conduct R. 6.1. This is not a mandatory 

rule. See Note, Amended Rule 6.1: Another Move 

Towards Mandatory Pro Bono Is That What We Want, 7 

Geo. J. Legal Ethics 1139 (1994). In most states, pro bono 

representation remains an aspiration, which makes it a 

matter of professional fulfillment, rather than a matter 

of ethics. See Policies—State Pro Bono Ethics Rules, Am. 

Bar Ass’n (Jan. 20, 2012), http://www.americanbar.org/groups/ 

probono_public_service/policy/state_ethics_rules.html (last visited 

Sept. 13, 2012). 

For the most part, lawyers understand their responsibility 

to do free work for the poor. We aspire to do pro 

bono work, not because it is the right thing to do, or 

because it makes us feel good, but because it is a vocation 

of our profession. We have received a unique and 

exclusive privilege to provide legal advice and representation. 

The comments to Model Rule 6.1 remind us that 

“[e]very lawyer, regardless of professional prominence 

or professional work load, has a responsibility to provide 

legal services to those unable to pay and personal 

involvement in the problems of the disadvantaged can 

be one of the most rewarding experiences in the life of a 

lawyer.” Model Rules of Prof’l Conduct 6.1 cmt. 1. 

The breadth of Model Rule 6.1 likely was designed to 

cast the widest possible net for pro bono. A lawyer should 

be heartened by the wealth of opportunities that satisfy 

it. You can provide legal services to persons of limited 

means. You can provide legal services to charitable, religious, 

civic, community, governmental, and educational 

organizations designed primarily to address the needs of 

persons of limited means. The rule reflects your skill set, 

interest, or expertise. 

The legal needs of the poor are great. Although public 

defenders, poverty law centers, law students in law clinics, 

and others partially fulfill the legal representation 

needs of the poor, the needs are so great that others still 

must fill the gap. Taking yourself from understanding to 

action can only occur if you take a professional interest 

in the need for your help and gain an awareness of the 

critical nature of the need. 

Once you understand the professional obligation and 

the need, you must begin thinking of the ways that you 

can meet your professional responsibility to do pro bono 

work. It is difficult to translate that understanding into 

an undertaking. We often exaggerate the effect that taking 

a pro bono case will have on our practices and underestimate 

the tremendous effect that we can have if we 

take a case for a pro bono client. Keep in mind that you 

are immediately competent to do what you do in paying 

practice for free. On the other hand, you can become 

competent to do something that you have not dreamed of 

since law school. If you are a trial lawyer, learn to advise 

a nonprofit board. If you are a medical malpractice lawyer, 

learn immigration law. If you are an insurance coverage 

lawyer, represent kids in juvenile proceedings. 

Sometimes we forget about the breadth of our education 

and how it has prepared us to do many things. Countless 

local and national organizations would be happy to train 

you to begin undertaking pro bono representation. Many 

state and local bar associations have active pro bono 

programs, and your state or local defense organization 

may also have established pro bono service connections. 

Often the same pro bono group that trains you will ask 

you to handle cases. Unlike your daily practice, you will 

never, ever, struggle to find clients. And DRI members 

have a proud pro bono representation tradition. See “DRI 

Cares Honor Roll,” http://www.dri.org/About/Cares (then follow 

“Click here” hyperlink). 

■■ 

Thomas A. Gilligan, Jr., is a shareholder with Murnane Brandt in St. Paul, Minnesota. 

Mr. Gilligan’s trial and appellate practice focuses on product liability, employment, 

and personal injury litigation in Minnesota and Wisconsin. Mr. Gilligan serves 

as publications chair for the DRI Lawyers’ Professionalism and Ethics Committee 

When you have selected your interest area and develand 

is a former investigator for the Ramsey County District Ethics Committee. Ethics, continued on page 81 


Successor, from page 34 

vide some insight into why the states that 

failed to pass the legislation have rejected it. 

Conclusion 

While more and more state legislatures 

grapple with whether to grant some 

reprieve to successor companies that have 

not had asbestos industry involvement, 

asbestos plaintiffs’ lawyers continue to 

seek ways to expand traditional principles 

of successor liability to reach more 

and deeper pockets. At the same time, the 

courts continue to balance applying traditional 

successor liability principles to product 

liability litigation, assessing whether 

to expand successor liability theories to 

accommodate the litigation or wait for legislatures 

to speak on this issue. Until the 

legislatures do speak, successor companies 

will continue the delicate dance required 

to protect against tort liability that they 

did not create to guarantee their long-term 

viability. 

Nurse Paralegal, from page 21 

conclusion of a case because they remain 

accessible electronically. 

Trial Notebooks 

Many lawyers advocate using a trial notebook 

in a three-ring binder that a nurse 

paralegal will prepare. Other firms do not 

use trial notebooks. If a firm uniformly 

organizes files, as our firm does, a nurse 

paralegal and his or her supervising attorney 

will know where to locate documents 

in a file, and the file itself can serve as a 

trial notebook. 

Furthermore, because we save and scan 

all important documents to the firm’s computer 

system, we can copy them easily and 

have them readily accessible during a trial 

on a laptop computer or an iPad, if for some 

reason the paper document proves elusive. 

On one occasion, an enterprising paralegal 

in our firm placed a large portion of a 

file into a three-ring binder trial notebook 

just before a trial. During the trial, neither 

the nurse paralegal nor the trial attorney 

could locate documents readily in either 

the trial notebook or in the file from which 

the paralegal had removed the documents. 

Fortunately, they could access the necessary 

documents on the computer. 

Trial 

One role of the nurse paralegal is to make 

certain to locate all the necessary subfiles 

and make sure that they are filed correctly 

and immediately accessible during a trial. 

The nurse paralegal also verifies that all the 

documents in the firm’s computer system 

that relate to a case are stored on the attorney’s 

laptop computer and the nurse paralegal’s 

laptop computer. 

The nurse paralegal uses a checklist to 

assemble all the items that he or she and 

the supervising attorney will need during 

a trial. The checklist is comprehensive 

and calls for a primary and a backup of all 


electronic devices. During a trial, the nurse 

paralegal sets up the presentation equipment 

as needed, makes sure that each piece 

functions properly, troubleshoots problems 

with the equipment, and assists the trial 

counsel with displaying images. 

The nurse paralegal should participate 

in jury selection. A defense attorney should 

not select a jury alone. It is difficult if not 

impossible for one attorney to pose clear 

questions to prospective jurors, remember 

all the answers of each person, recall 

the intonation of each answer, and observe 

important nonverbal cues from all members 

of the group. Various studies indicate 

that most communication that discloses 

the truth is nonverbal rather than verbal. 

Generally, a nurse paralegal, due to training 

and experience as a nurse, is skilled 

in “reading” people and is in an excellent 

position during voir dire to form impressions 

and to make notes about them. An 

examining attorney probably can determine 

which prospective jurors to strike for 

cause without assistance. He or she may 

also discern which prospective jurors dislike 

the attorney without assistance. However, 

beyond that, he or she should allow 

the nurse paralegal and the physician client 

to suggest questions, and the attorney 

should seek significant input from them on 

excluding and selecting individuals from 

the jury pool. 

The nurse paralegal is deeply involved in 

preparing the PowerPoint presentation that 

the defense attorney in our firm generally 

will use in the opening statement of a trial. 

The nurse paralegal has unique insight into 

how to use medical illustrations, timelines, 

and other demonstrative evidence effectively 

to introduce complex medical issues 

to a jury. The nurse paralegal helps ensure 

that all the visual aids are medically valid 

and factually accurate. Although opinions 

conflict on what percentage among jury 

members make up their minds during 

opening statements, most attorneys believe 

that the opening statements are among the 

most important parts of jury trials. 

During a trial, in our firm the nurse 

paralegal types notes on a laptop computer 

for use by the attorney during the trial and 

for reporting the progress of a case to the 

insurer at the conclusion of each trial day. 

The nurse paralegal’s notes are particularly 

useful to the attorney when the time comes 

to prepare the closing argument. 

Conclusion 

For attorneys who engage in the defense 

of medical professionals and institutions, 

working with a nurse paralegal has become 

almost obligatory. Attorneys for plaintiffs 

recognize their value and increasingly 

employ a nurse paralegal or a legal nurse 

consultant. 

The value and level of participation of 

a nurse paralegal depends on his or her 

qualifications and characteristics, which 

optimally should include intelligence, communication 

skills, empathy, and curiosity. 

A capable nurse paralegal can educate an 

attorney invaluably, assist with case management, 

relate professionally to clients, 

obtain and comment on medical records, 

create a medical chronology, interact effectively 

with experts, conduct medical literature 

research, assist in preparing a client 

for the client’s deposition, review file organization, 

assist with trial preparation, and 

aid an attorney during a trial. 

A defense attorney who has the good 

fortune of having a long- standing working 

relationship with a nurse paralegal 

often finds it difficult to imagine how his 

or her defense practice could function as 

effectively without that nurse paralegal. 

Attorneys who currently do not work with 

such nurse paralegals can find intelligent, 

curious nurses with good communication 

skills willing to assist defense attorneys in 

representing clients with excellence.

Ethics, from page 79 

oped competency, it is time to step over the 

threshold. As a professional, you will need 

to treat a pro bono case as you would any 

other representation for which you receive 

compensation. Just as you would handle a 

case for a client for which you received $150 

per hour the same as you would handle 

one for which you received $350 per hour, 

your pro bono client would have the right 

to nothing less than your focused attention 

and most outstanding representation. In 

fact, I predict that the financial, emotional, 

and psychological vulnerability of your pro 

bono client likely would spur you to work 

that much harder to succeed. 

Lawyers should perceive pro bono representation 

as an entitlement of the profession 

rather than as an obligation. As 

professionals, we don’t need a mandatory 

rule to understand that pro bono work 

is integral to being lawyers. As Justice 

Anthony Kennedy once observed, “it is precisely 

because our duties go beyond what 

the law demands that ours remains a noble 

profession.” 

Read the rule. Turn aspiration into 

action. Search for training. Take on a client. 

Show up. 

Think Globally, from page 78 

Switzerland with the German- influenced 

and Austrian- influenced trial systems of the 

other mainly German- speaking cantons. So 

not surprisingly, the enactment of collective 

redress schemes in the Swiss Civil Procedural 

Code (SCPC) was never discussed seriously, 

not only due to fears of overloading 

the legislative boat, but also due to profound 

scepticism about the perceived excesses of 

the U.S. class action system. 

It is somewhat predictable that in the 

future Switzerland will again discuss 

whether to amend the SCPC of 2011 to 

include collective redress mechanisms. 

Efforts to introduce collective redress systems 

in Switzerland might achieve momentum 

again in light of numerous mass cases 

in the banking, insurance, and fund industries 

during the ongoing financial crisis that 

started in 2007. The Swiss telcom industry 

with its de facto monopoly and the view 

that its consumers pay too much might also 

generate discussions about whether collective 

redress could lead to substantial telcom 

price decreases, while similar factors apply 

to Swiss consumers affected by a fair number 

of still existing horizontal monopolies. 

A harmful deep-heat mining project in 

2007 causing an earthquake that resulted 

in thousands of home owners experiencing 

home damage in the Greater Basel 

Area might also fuel the discussion about 

whether the “access to courts” guaranteed 

by the Swiss Constitution must be secured 

through collective redress schemes. 

Magic Number, from page 72 

When a plaintiff needs to tie causation 

to one or more particular defendants 

in a toxic tort case, the case will consider 

whether an exposure attributable to the 

defendants was, indeed, a “substantial factor” 

or a “substantial contributing factor” 

and a “significant” or a “significant contributing 

factor” in the development of the disease 

or injury, and perhaps even whether 

that disease would have developed “but 

for” that “exposure” or the defendant’s 

conduct. Testimony offered on these topics 

moves from the scientific to the hypothetical 

and has spawned a variety of unspecific 

and very unscientific “catch phrases” summarizing 

the bases of causation opinion 

theories, including “any exposure,” “any 

exposure above background,” “all exposures,” 

and the infamous hypothetical “one 

fiber” theory. Unfortunately courts have 

accepted many of these theories as “scientific” 

without considerable analysis or scrutiny. 

These are offered as both an opinion 

and the basis for an ultimate opinion that 

an “exposure” was a substantial factor in 

the development of a plaintiff’s disease or 

injury. They are generally offered because 

in many circumstances someone cannot 

say that a specific “exposure” was sufficient 

to cause the injury, or in a multiparty 

case, which exposure or exposures were 

causative or sufficient to cause disease. 

They allow an expert to opine on causation 

after as little as two minutes of scientific 

“inquiry” regarding the generalities about 

a particular case. 

Though the question of whether there 

is evidence suggesting a causal relationship 

is by no means the only necessary 

inquiry when examining expert opinion 

testimony on causation and understand- 

ing that epidemiology and, specifically, 

although a relative risk that is > 2.0 is not 

a “philosopher’s stone” that will turn unreliable 

science into gold, when the medical 

and scientific literature presents reliable 

evidence of a statistically significant relative 

risk that is > 2.0, it may provide a scientific 

basis for a causation opinion on 

a more likely than not basis. And while 

all practitioners and courts do not agree 

that a statistically significant doubling of 

a risk demonstrated by reliable epidemiological 

evidence absolutely is required to 

demonstrate the admissibility of an expert 

opinion regarding a cause and effect relationship 

between an agent and a disease 

or injury, when assessing the legal and scientific 

validity of such expert opinion testimony 

on causation, 2.0 really is a magic 

number. Yes it is. It’s a magic number. 

Off-Label, from page 27 

tionally with the law because it restricted 

the availability of information that many 

people find very helpful) (internal citations 

and quote marks omitted). 

The federal ban on offlabel drug-use 

marketing is analogous to the Vermont law 

that the U.S. Supreme Court found unconstitutional: 

at its most basic level, the FDA 

has prohibited commercial speech, offlabel 

drug-use marketing, without regard for its 

truthfulness, out of concern that it would 

unduly persuade the public to make bad 

decisions. This concern is not a valid justi- 

fication for restricting commercial speech 

because “[t]he choice ‘between the dangers 

of suppressing information, and the dangers 

of its misuse if it is freely available’ is 

one that ‘the First Amendment makes for 

us.’” Id. at 2671 (quoting Va. State Bd. of 

Pharmacy, 425 U.S. at 770). Accord Thomp- 


son, 535 U.S. at 375. Furthermore, since 

the FDA probably could achieve the narrowly 

stated goal of encouraging manufacturers 

to seek approval for all indications 

through less restrictive means, the regulation 

and policies articulated in the FDA 

draft guidance may only await a constitutional 

challenge by a manufacturer on First 

Amendment grounds. 

Conclusion 

The FDA’s stated mission is to ensure that 

all drugs and devices are safe and effective. 

This is a noble goal which no drug manufacturer, 

physician, or patient could find 

fault with. However, the FDA’s prohibition 

on offlabel marketing and the recent Guidance 

clarifying its policy on responding to 

unsolicited requests for offlabel information 

do little to advance that goal. The net 

result of recent policy announcements will 

be that drug manufacturers are too constrained 

and fearful to provide truthful 

and valuable information about offlabel 

uses, even in the limited instances when 

the Guidance provides an opportunity to 

do so. Consequently, doctors may not be 

fully informed and patients may not receive 

the latest innovative therapies. It is time for 

the FDA to rethink their policy towards offlabel 

marketing, and recent First Amendment 

jurisprudence suggests the courts 

may be willing to do it for them upon the 

appropriate challenge. 

Greater, from page 29 

and volunteer to get involved. I think that 

you will find this committee to be one of 

the most energized committees in DRI. I 

have known some of these people for 27 

years, and consider many of them to be 

close friends. 

Every committee chair should have a 

vice chair as fantastic as Patrick Sweeney. 

Pat is great to work with. Our Law Institute 

representative is Paul Lavelle. I have 

known Paul for decades. Paul takes his 

job with the Law Institute extremely seriously 

and really encourages this committee 

to improve with each year. When you 

see the programs and the quality of the 

speakers that we have, think of all the hard 

work that Paul Lavelle put into the programming, 

and understand that Anne Talcott 

and James Weatherholtz have worked 

nights and weekends to put this next seminar 

together. 

I have a great committee. I want to make 

it greater. If you ever think of anything that 

we can do to improve the committee, please 

shoot me an email or give me a call. I look 

forward to seeing everyone in April! 

2013 

Seminar 

Schedule 

January 24–25 

January 31– 

February 1 

February 28– 

March 1 

March 13–15 

March 20–22 

March 21–22 

April 3–5 

April 10–12 

April 24–26 

Fire Science and Litigation 

FireSky Resort, Scottsdale, AZ 

Civil Rights and Governmental Tort Liability 

Arizona Biltmore, Phoenix, AZ 

Toxic Torts and Environmental Law 

The Ritz-Carlton, New Orleans, New Orleans, LA 

Women in the Law 

Eden Roc Renaissance Miami Beach, Miami Beach, FL 

Trial Tactics 

Paris Las Vegas, Las Vegas, NV 


Eden Roc Renaissance Miami Beach, Miami Beach, FL 

Product Liability Conference 

Gaylord National, National Harbor, MD 

Insurance Coverage and Claims Institute 

Swissôtel Chicago, Chicago, IL 

Life, Health, Disability and ERISA Claims 

Westin Copley Place, Boston, MA 


Advocates 

Jackson H. Ables III, 

Jackson, MS 

Lucinda H. Alfieri, 

New York, NY 

Robert B. Anderson, 

Wilmington, DE 

Alison Y. Ashe-Card, 

Winston Salem, NC 

Shaun McParland Baldwin, 

Chicago, IL 

Whitney Kirkpatrick 

Barrows, Boston, MA 

Jeremy Edward Beal, 

Fullerton, CA 

Peter Blomquist, 

Houston, TX 

Matthew J. Boettcher, 

Bloomfield Hills, MI 

Douglas M. Borochoff, 

Tulsa, OK 

Advocates and New Members 

Each month, DRI welcomes new members from the United States and Canada and abroad. Some of these new 

members have been recommended by current members actively involved in advancing goals shared by DRI. Any 

individual who recommends a new member is recognized as an “Advocate” for DRI. 

John S. Bradford, 

Lake Charles, LA 

C. William Bradley, Jr., 

New Orleans, LA 

Sean P. Byrne, Glen Allen, VA 

Christopher G. Campbell, 

New York, NY 

Rina Carmel, 

Los Angeles, CA 

Alexis A. Chmell, Chicago, IL 

Jessica Cochran, Tampa, FL 

Clark H. Cole, Saint Louis, MO 

Darren A. Craig, 

Indianapolis, IN 

J. Tyler Dinsmore, 

Charleston, WV 

Tony Alan Discoe, 

Santa Ana, CA 

Terese A. Drew, 

Saint Louis, MO 

Andre Durocher, 

Montreal, QC 

Glenn P. Falk, 

Coral Gables, FL 

J. Victor Flanagan, 

Charleston, WV 

James R. Gallagher, 

Columbus, OH 

Christine Gateau, 

Paris, France 

Daniel W. Gerber, Buffalo, NY 

Alessandro P. Giorgetti, 

Milan MI, Italy 

Wayne Glaubinger, 

New York, NY 

John J. Hainkel III, 


William M. Hake, 

San Francisco, CA 

Joseph M. Hanna, 

Buffalo, NY 

Michelle Harris, Tulsa, OK 

Cary E. Hiltgen, 

Oklahoma City, OK 

Edward G. Hochuli, 

Phoenix, AZ 

James D. Holland, 

Jackson, MS 

Michael J. Hudak, 

Akron, OH 

John J. Jablonski, 

Buffalo, NY 

Glenn A. Jacobson, 

New York, NY 

Bonnie Elaine Roberts 

Jones, Toronto, ON 

Philip E. Kalamaros, 

Saint Joseph, MI 

Richard E. King, 


Joshua Edward Mackey, 

Poughkeepsie, NY 

Michael T. McConnell, 

Denver, CO 

Terrence R. McInnis, 

Irvine, CA 

Stuart P. Miller, 

Little Rock, AR 

Julius F. Parker III, 

Tallahassee, FL 

Patrick J. Paul, Phoenix, AZ 

Samuel L. Phillips, 

San Jose, CA 

Katherine L. Rhyne, 

Washington, DC 

Sherry Ruggiero-Fallon, 

Wilmington, DE 

Jeffrey R. Simmons, 

Phoenix, AZ 

Josh M. Snell, Phoenix, AZ 

John R. Trigg, Denver, CO 

James E. Tyrrell, Jr., 

Newark, NJ 

Kristopher T. Wilson, 


Kurt M. Zitzer, Scottsdale, AZ 

Michael C. Zogby, 

Florham Park, NJ 

May 1–3 

May 9–10 

May 9–10 

May 16–17 

May 16–17 

May 30–31 

June 6–7 

June 13–14 

June 20–21 

Employment and Labor Law 

Arizona Biltmore, Phoenix, AZ 

Business Litigation 

InterContinental Chicago, Chicago, IL 

Intellectual Property 



Sheraton New York Hotel, New York, NY 

Retail and Hospitality Litigation and Claims Management 


Diversity for Success 

Swissôtel Chicago, Chicago, IL 

Insurance Bad Faith and Extra-Contractual Liability 

Westin Boston Waterfront, Boston, MA 

DRI International 

Prague Marriott Hotel, Prague, Czech Republic 

Young Lawyers 

The Cosmopolitan of Las Vegas, Las Vegas, NV 


New Members 

Arizona 

John L. Condrey, Phoenix 

Chelsey Marie Golightly, 

Phoenix 

Jason Kasting, Phoenix 

Molly C. Machold, Phoenix 

Rose McCaffrey, Phoenix 

Nathan T. Mitchler, Phoenix 

Molly NewBurn, Phoenix 

Rob A. Justman, Scottsdale 

Jordan Plitt, Scottsdale 

Arkansas 

Megan Hargraves, 

Little Rock 

Chad William Pekron, 

Little Rock 

California 

Jason Rouss, Carlsbad 

James E. Bullard, Fullerton 

Anthony Joseph 

Parascandola, Gardena 

Mohammed Mandegary, 

Irvine 

Maria Louise Cousineau, 

Los Angeles 

Jeffrey S. Kaplan, 

Los Angeles 

Cheryl A. Orr, Los Angeles 

Gregory J. Rockwell, 

Oakland 

Katherine Renee Moore, 

Redwood City 

Nicolas P. Martin, 

San Francisco 

Matthew A. Zavala, 

Santa Ana 

Joel F. Citron, Santa Monica 

Thomas H. Citron, 

Santa Monica 

Colorado 

Joseph W. Gren, Denver 

Walter N. Houghtaling, 

Denver 

Stephen Oertle, Denver 

Justin Akira Zaharris, 

Denver 

Delaware 

Sarah Roberts, Newark 

Carrie Kehner, Wilmington 

District of Columbia 

Charles Anthony Jones, 

Washington 

Lauren Reeder McClurg, 

Washington 

Jordan M. Rubinstein, 

Washington 

Florida 

Khristen Vachal-Reese, 

Coral Gables 

Rose Marie Antonacci- 

Pollock, Fort Lauderdale 

William David Jester, 

Pensacola 

Carrie M. Roane, 

Tallahassee 

Julie Anne Berlick, Tampa 

Allan Crosby Crane, Tampa 

Kimberly Gorak, Tampa 

Georgia 

Elizabeth Loraine Edwards, 

Atlanta 

Ashley Gowder, Atlanta 

W. Hensell Harris, Atlanta 

Mary Claire Jagor, Atlanta 

Justin David Kreindel, 

Atlanta 

Jennifer Neison Herman, 

Savannah 

Hawaii 

Lyle Y. Harada, Honolulu 

Idaho 

Jaren N. Wieland, Boise 

Illinois 

Matthew Bigham, Belleville 

Alexis A. Chmell, Chicago 

Mark Joseph Lura, Chicago 

Lisa Mazzone, Chicago 

Karen Vivian Nathan, 

Chicago 

John P. Sullivan, Chicago 

Indiana 

Michele Lorbieski Anderson, 

Indianapolis 

Ashley Butz, Indianapolis 

Iowa 

Andrew F. Van Der Maaten, 

Decorah 

Joel Yunek, Mason City 

Kansas 

Kim Donica Farha, Wichita 

Kentucky 

Judd R. Uhl, Covington 

Vonda F. Kirby, Louisville 

Rebecca Schafer, Louisville 

Louisiana 

Todd Michael Ammons, 

Lake Charles 

Natalie J. Dekaris, 

New Orleans 

Crystal E. Domreis, 

New Orleans 

Michael C. Mims, 

New Orleans 

Travis B. Wilkinson, 

New Orleans 

Rebecca A. Zotti, 

New Orleans 

Massachusetts 

Alexandra L. Geiger, Boston 

Michael J. Leard, Boston 

Margaret S. Moran, Boston 

Kaitlin Shea Moroney, 

Boston 

Steven M. O’Brien, Boston 

Kevin Truland, Boston 

Michigan 

Marc P. Jerabek, 

Bloomfield Hills 

Brad Pero, Saint Joseph 

Mississippi 

G. Todd Butler, Jackson 

JoAnne Nelson Shepherd, 

Jackson 

Roy A. Smith, Jr., Jackson 

Elizabeth E. Hyde, Oxford 

Missouri 

Phebe La Mar, Columbia 

Brian Mayer, Kansas City 

Nazish Shabbir, Kansas City 

Timothy M. Etzkorn, 

Saint Louis 

Steven Wolin, Saint Louis 

New Jersey 

James A. Long, Florham Park 

Joseph E. Hopkins, Newark 

Richard J. Reisert, 

North Bergen 

Maria Tavano, Wayne 

New Mexico 

Tyler M. Cuff, Albuquerque 

Emma D. Boawn, Santa Fe 

New York 

Amy H. Chung, New York 

Domenick Charles Di Cicco, 

Jr., New York 

Priyanthi Gunasekera, 

New York 

Hilary Henkind, New York 

Dennis J. Monaco, New York 

Graig Russo, New York 

Robert M. Weber, New York 

Omer Gil, Poughkeepsie 

Joseph A. Orlando, 

Putnam Valley 

Katrine Aliha Beck, 

White Plains 

Jill C. Owens, White Plains 

North Carolina 

Louis F. Foy III, Goldsboro 

Mary Boyce Wells, Raleigh 

Sonny S. Haynes, 

Winston Salem 

Ohio 

Stacy R. Delgros, Akron 

M. Jason Founds, 

Columbus 

Oklahoma 

Jennifer A. Bruner, 

Oklahoma City 

Daniel Burstein, 

Oklahoma City 

Charles A. McSoud, Tulsa 

Rachel Parrilli, Tulsa 

Oregon 

Laura Althouse, Portland 

Lisa A. Amato, Portland 

Pennsylvania 

Candy Barr Heimbach, 

Bethlehem 

Jason C. Glurintano, 

Harrisburg 

Mark Skinner, Philadelphia 

Leigha Coon, Pittsburgh 

Matthew J. Connell, 

West Chester 

Rhode Island 

Joseph M. Codega, 

Providence 

Erin Illuzzi, Providence 

Jeffrey Pethick, Providence 

South Carolina 

Kenny Gardner, Charleston 

M. Britton Mason Hawk, 

Charleston 

A. Grayson Smith, Columbia 

Childs Cantey Thrasher, 

Columbia 

Amanda Bradley, Greenville 

Ammon Tice Lesher, 

Greenville 

Burl F. Williams, Greenville 

Tennessee 

R. Scott McCullough, 

Memphis 

Texas 

Peter J. Strelitz, Austin 

Jeffrey L. Stewart, Boerne 

Nathan Aduddell, Dallas 

Camille Johnson, Dallas 

Michael E. Schonberg, 

Dallas 

Brian Stoltz, Dallas 

Mackenzie Wallace, Dallas 

David Moises Mirazo, 

El Paso 

LaVerne Chang, Houston 

Julie Countiss, Houston 

Daniel R. Erwin, Houston 

Laura B. Herring, Houston 

Barclay Nicholson, Houston 

Stephen R. Wedemeyer, 

Houston 

Alison White Haynes, Laredo 

Frank Sabo, Jr., McAllen 

Kathryn A. Stephens, 

San Antonio 

Preston Worley McGee, Tyler 

Michael Morrison, Waco 

Joe Rivera, Waco 

Utah 

S. Grace Acosta, 

Salt Lake City 

Troy L. Booher, Salt Lake City 

Tajha Ferrara, Salt Lake City 

Mark Huber, Salt Lake City 

Isaac James, Salt Lake City 

Anna Nelson, Salt Lake City 

Rafael A. Seminario, 


Patrick L. Tanner, 


Vermont 

Andrew A. Beerworth, 

Burlington 

Jennifer E. McDonald, 

Burlington 

Thomas P. Simon, Burlington 

Virginia 

Samuel T. Bernier, Glen Allen 

Sean Hanifin, McLean 

Timothy L. Creed, Norfolk 

Washington 

David Norman, Seattle 

West Virginia 

Linnsey Marie Amores, 

Charleston 

William J. Cooper, Charleston 

John D. Hoffman, Charleston 

Nic Dalton, Wheeling 

Wisconsin 

Jennifer M. Luther, Madison 

Laurel Johnson, Milwaukee 

Wyoming 

Ronald J. Lopez, Cheyenne 

Canada 

Ontario 

Matthew John Diskin, 

Toronto 

Quebec 

Peter E. Kirby, Montreal 

France 

Emmanuele Lutfalla, Paris 

Pierre Seguin, Paris 

Ireland 

Eimear Collins, Dublin 

United Kingdom 

Clive O’Connell, London 

Eleni Iacovides, London 

Tanguy Francois Marie Le 

Gouellec de Schwarz, 

London 


The word research may instantly bring many things to mind 

for you. Chances are, these thoughts involve lots of reference 

searches, surveys and analyzing reams of statistical data. 

and out there in the real world. In fact, many of the 

innovative tests developed at S-E-A have become industry 

and government standards. 

At S-E-A, our staff of researchers, technicians and investigators 

relish these tools as much as anyone, but for us, they 

are only the beginning. Because we are very rarely asked for 

So it’s really no wonder that we have our own definition of 

research. We have made a habit of expanding it. That’s not a 

habit we have any plans to change. 

answers that are readily apparent. 

So whatever the word research brings to mind for you, when 

Whether conducting a forensic investigation to establish 

what really happened to cause injury or damage, 

you need real answers that aren’t readily apparent or 

available, that should definitely bring S-E-A to mind. 

or pre-market testing to help manufacturers 

mitigate risk and increase the safety of their 

products, S-E-A’s idea of research encompasses 

a wide range of engineering disciplines working 

together to find answers that stand up in court 

Visit www.SEAlimited.com 

or call Jason Baker at 

800-782-6851 for more details. 

 

Scientific Expert Analyisis 

© 2012

SAVE THE DATE 


Conference 

Make Your Products 

Practice Bloom in 2013 

April 3–5, 2013 

Gaylord National Hotel 

National Harbor, Maryland 

DRI is excited to move the Product Liability 

Conference east of the Mississippi for 2013. Enjoy the 

blooming of the cherry blossoms in the Washington 

D.C. area while learning the latest trends and 

decisions affecting product liability cases. 

Regulators from the NTSB, NHTSA and CPSC and 

manufacturers and lawyers who navigate these 

agencies regularly will discuss best practices for 

minimizing liability before and during litgation. 

Offering 18 hours of CLE credit, attendees will 

receive valuable practice tips, strategies and trial 

techniques to gain an advantage in defending 

modern product liability cases. 

Visit http://dri.org/Events/Seminars 

or call 312.795.1101 

to register or for 

more information.

For The Defense, November 2012 - DRI Today

Create successful ePaper yourself

Delete template?

Save as template?